Z-1675-2021Class II

IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 -

Name: Z-1675-2021 IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 -
Creator: Roche Diagnostics Operations, Inc.
Published: 2021-04-26
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2021-04-26 / Open, Classified / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in... on 2021-04-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1675-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-26
Posted: 2021-05-24
Recalling firm: Roche Diagnostics GmbH
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 04/26/2021, Roche issued an Urgent Medical Device Correction notice to customer via letter notifying them of issues regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c 311, 501, and 502 analyzers and on the COBAS INTEGRA 400 plus analyzer.
Quantity in commerce: 20,468 kits
Distribution: US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Product codes and lots: UDI: 04015630918904

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1675-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1675-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-02	2021-05-24

Product code JJE

K951595Class IIRoche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. / cleared 1995-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)