Z-0489-2025Class II

cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in...

Name: Z-0489-2025 cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in...
Creator: Roche Diagnostics Operations, Inc.
Published: 2024-10-17
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2024-10-17 / Open, Classified / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine on 2024-10-17. FDA classified it as Class II and gives the reason as "Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)". 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-0489-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-17
Posted: 2024-11-19
Recalling firm: Roche Diagnostics GmbH
Product: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Product code: LPS Urinary Homocystine (Nonquantitative) Test System
Reason for recall: Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Roche issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 10/17/2024 via UPS Ground. The notice explained the issue, clinical significance, and requested the following actions be taken: "" HCYS kits lot number 747029 expired on September 30, 2024. Ensure any inventory you have of this lot has been discarded per your local guidelines. " Follow your laboratory s standard operating procedures to determine specific clinical implications for your patients and whether retrospective review of patient results is required. " Consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site." For questions: contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336
Quantity in commerce: 458 units
Distribution: US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
Product codes and lots: UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0489-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0489-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-19

Product code LPS

K113793Class IIHomocysteine TestRoche / cleared 2012-06-05

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)