Device product
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.
Z-1979-2019
Product summary
- Event
- Event 83095
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-1979-2019
Official wording
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.
Code information: Lot 368756
Distribution pattern: The products were distributed to the following US states: AL, IN, and KY.
Derived failure modes
-
Unknown
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.