Z-1979-2019 Class II Terminated
FDA device recall Z-1979-2019 was initiated by Roche Diagnostics Corporation on June 3, 2019 and is designated Class II. 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. The recall status is terminated (terminated August 28, 2020). Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2019
- Initiation Date
- June 3, 2019
- Termination Date
- August 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product 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 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 Pattern
The products were distributed to the following US states: AL, IN, and KY.
Code Information
Lot 368756