Recall Z-0103-2021— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0103-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-27

Class III · Terminated

Class III FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2020-08-27, terminated 2024-05-22. It names one FDA 510(k) clearance: K012359. Product: Tina-quant Complement C4 ver.2, Catalog 05991994190. Reason: Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class III
Status: Terminated
Initiated: 2020-08-27
Terminated: 2024-05-22
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K012359 — TINA-QUANT COMPLEMENT C4 TEST SYSTEMRoche Diagnostics Corp.·cleared 2001-11-29

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

Tina-quant Complement C4 ver.2, Catalog 05991994190

Reason for recall

Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

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