Recall Z-1675-2021— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-1675-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-26

Class II · Ongoing

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2021-04-26. It names one FDA 510(k) clearance: K951595. Product: IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.. Reason: Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-04-26
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K951595 — ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESRoche Diagnostic Systems, Inc.·cleared 1995-09-08

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

IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.

Reason for recall

Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.

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