FDA Recall
Terminated
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.
Recall: Z-1979-2019
·
Initiated June 3, 2019
Recall
- Recall Number
- Z-1979-2019
- Event Number
- 83095
- Firm
- Roche Diagnostics Corporation
- FEI Number
- 1823260
- Product Code
- CZP
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- June 3, 2019
- Terminated
- August 28, 2020
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025
Description
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.
Reason
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.
Action
Urgent Medical Device Correction notification letters dated 6/3/19 were sent to customers.
Distribution
The products were distributed to the following US states: AL, IN, and KY.
Quantity
8 units