Recall Z-0152-2020— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0152-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-11

Class III · Terminated

Class III FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2019-09-11, terminated 2024-06-11. It names one FDA 510(k) clearance: K033009. Product: Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.. Reason: Due to low Quality Control recovery and invalid Calibration..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class III
Status: Terminated
Initiated: 2019-09-11
Terminated: 2024-06-11
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K033009 — ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2Roche Diagnostics Corp.·cleared 2003-10-16

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

Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.

Reason for recall

Due to low Quality Control recovery and invalid Calibration.

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