Recall Z-1979-2019— Roche Diagnostics Corporation

Name: FDA recall Z-1979-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-03

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2019-06-03, terminated 2020-08-28. It names one FDA 510(k) clearance: K040435. 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.. 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..

Recalling firm: Roche Diagnostics Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-06-03
Terminated: 2020-08-28
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K040435 — ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.·cleared 2004-03-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.