Lower riskMedical device recall · FDA · Published October 17, 2024
Roche cobas HCYS Assay Recall: Erroneous Test Results Risk
Roche recalls cobas HCYS Homocysteine Assay (Material REF 06542921190) for potential erroneous patient test results. Affected units sold with cobas c 701/702 devices.
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
“Roche cobas HCYS Assay Recall: Erroneous Test Results Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53685-roche-cobas-hcys-assay-recall-erroneous-test-results-risk. Based on FDA recall #Z-0489-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0489-2025%22&limit=1).
Roche Diagnostics Operations, Inc. recalled the cobas HCYS Homocysteine Enzymatic Assay on Oct. 17, 2024, after the FDA announced the Class II recall due to potential erroneous patient results. The agency cited abnormal calibration signals and control recovery issues as the hazard.
How to tell if you have it
Brand: Roche
Product: cobas HCYS, Homocysteine Enzymatic Assay
Material Number: REF 06542921190
Lot Number: 747029
Expiration Date: 30-SEPT-2024
Units Affected: 458
The hazard
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results, including positive or negative bias. The FDA stated these errors could lead to misdiagnosis.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has issued 32 other recalls since July 2, 2019. Recent similar recalls include the Roche cobas pro integrated solutions recall on Jan. 20, 2026, and the Roche Elecsys Anti-TSHR Assay Recall on Nov. 21, 2025. Other recent recalls of similar products include the Siemens Atellica CH A1c_E Test Recall (June 8, 2026), the Siemens Atellica CH Urine Albumin Recall (July 6, 2026), and the Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026).
How to tell if you have this one
Check for the Material Number REF 06542921190 on the cobas HCYS assay. The assay is sold with cobas c 701/702 devices for homocysteine blood tests.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Assay Details
Look for the Material Number REF 06542921190 on the cobas HCYS assay label.
Where it went and when
Where it was distributed
Distributed in 8 states.
Listed by the agency
Not listed
FDA distribution: “US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Indiana, Iowa, New Jersey, New York, Oklahoma, South Carolina, Texas.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0489-2025 (October 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0489-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.