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.
- Company
- Roche Diagnostics Corporation
- Recall Initiated
- June 3, 2019
- Terminated
- August 28, 2020
- Recall Number
- Z-1979-2019
- Quantity
- 8 units
- Firm Location
- Indianapolis, IN
Reason for Recall
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.
Distribution
The products were distributed to the following US states: AL, IN, and KY.
Lot / Code Info
Lot 368756
Root Cause
Material/Component Contamination
Action Taken
Urgent Medical Device Correction notification letters dated 6/3/19 were sent to customers.
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