Reported Jul 24, 2019 · Terminated
The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form…
Roche Diagnostics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
- Lot codes and dates
- Lot 368756
- Amount recalled
- 8 units
Where it was sold
Why it was recalled
Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
This product could cause temporary or reversible health problems — stop using it.
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