FDAFDA · Food and drugs·Recall number Z-1979-2019
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.
Published July 24, 2019 · Recall initiated: June 3, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Corporation
- Distributor
- The products were distributed to the following US states: AL, IN, and KY.
- Lot
- Lot 368756
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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