Bio-Rad Laboratories, Inc. Bio-Rad PTC-100

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Central / core laboratory
• Point-of-care testing stations
• Blood bank
• Microbiology lab

Documents & Manuals

• Bio-Rad PTC-100Document · External

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.

• RECALL

  There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.

• RECALL

  On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.

• RECALL

  It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.

• RECALL

  A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.

• RECALL

  Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results.

• RECALL

  Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes.

• RECALL

  Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass..

• RECALL

  The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated.

• RECALL

  The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits.

• RECALL

  The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.

• RECALL

  Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.

• RECALL

  The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability.

• RECALL

  The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually elevated positivity rate for patient samples tested.

• RECALL

  False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. False positive ANA values could result in misdiagnosis or mistreatment .

• RECALL

  The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantitation of the blood results.

• RECALL

  Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.

• RECALL

  Wrong lot number was found on the Hemoglobin Cartridge Insert . The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD.

• RECALL

  Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping baseline can affect hemoglobin test results.

• RECALL

  Product update kit CD rom will not upload. As a result, the device cannot be run.

• RECALL

  Incorrect patient results are being generated from out-of-range samples tested withc ompetitive enzyme immunoassays on the PhD system with software version 2.1A.

• RECALL

  The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.

• RECALL

  Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.

• RECALL

  The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.

• RECALL

  Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.

• RECALL

  Incorrect values: An error was found in the BioPlex 2200 Software, Version 2.0 that results in assignment values being utilized for the BioPlex assay Calibrator Set that may be slightly different from those printed on the Value Assignment Data Sheet. Some values may be identical between the lot assignment combinations with the ANA Screen with MDSS kit.

• RECALL

  The product may produce a faint line which could be interpreted as a false negative test result .

• RECALL

  The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.

• RECALL

  New instructions to recommend against using samples with visibly high level of blood.

• RECALL

  The device was producing false negative results for cocaine tests.

Related calculators

From BioLab, for work done with this kind of equipment.

• PCR Master MixComponent volumes for any number of reactions
• Primer TmPrimer melting temperature by four accepted methods, side by side
• qPCR ΔΔCtRelative gene expression by the 2^−ΔΔCt method
• DNA DilutionDilute a DNA or RNA stock to a working concentration