Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Nitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1835-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Blood Grouping ReagentDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1836-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Urease, Photometric, Urea NitrogenDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1837-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Multi-Analyte Controls, All Kinds (Assayed)Distribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1838-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Multi-Analyte Controls, All Kinds (Assayed)Distribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1839-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Calibrator, Multi-Analyte MixtureDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1840-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1841-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)Distribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1842-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: System, Test, Thyroid AutoantibodyDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1843-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: System, Test, Thyroid AutoantibodyDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1844-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Test, Hiv DetectionDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1845-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Electrode, Ion Based, Enzymatic, CreatinineDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1846-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)Distribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1847-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Calibrator, SecondaryDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1848-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Calibrator, SecondaryDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1849-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Calibrator, SecondaryDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1850-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Calibrator, SecondaryDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1851-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign ConditionsDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1852-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)Distribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1853-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Single (Specified) Analyte Controls (Assayed And Unassayed)Distribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1854-2025