Recall Z-1979-2019 ยท CZP Iga, Antigen, Antiserum, Control
Roche Diagnostics Corporation
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.
| Date | Jun 3, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Material/Component Contamination |
| Action | Urgent Medical Device Correction notification letters dated 6/3/19 were sent to customers. |
| Quantity | 8 units |
| Distribution | The products were distributed to the following US states: AL, IN, and KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040435 | ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 Roche Diagnostics Corp., Mar 10, 2004 |