Roche Homocysteine Test Recall: Calibration Failures Risk
Roche recalls homocysteine test kits for cobas c701/702 systems due to calibration failures. Affected lots may give inaccurate results. Contact Roche for details.
Lower-risk recall
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Contact the company
What happened, in plain English
Roche is recalling homocysteine test kits used with cobas c701 and c702 analyzers because they may have calibration issues. This could lead to inaccurate test results, which might affect medical diagnoses. Read more at govinfonow.com/recall/66892-roche-homocysteine-test-recall-calibration-failures-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/66892-roche-homocysteine-test-recall-calibration-failures-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0679-2020
Cite this page
“Roche Homocysteine Test Recall: Calibration Failures Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66892-roche-homocysteine-test-recall-calibration-failures-risk. Based on FDA recall #Z-0679-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0679-2020%22&limit=1).
Why it’s dangerous
The test kits may have calibration failures, leading to inaccurate results for homocysteine levels. This could affect medical diagnoses for conditions like hyperhomocysteinemia or homocystinuria.
Who’s affected
Healthcare professionals using Roche homocysteine test kits with cobas c701 or c702 analyzers. Patients receiving tests with these kits may be at risk of inaccurate results.
How to tell if you have this one
Check for the catalog number 06542921190 on the test kit. The lot number 422313 and expiration date 07/31/2020 are also associated with this recall.
- Brand
Roche- Category
Medical device
What to do — step by step
Check Kit Details
Look for the catalog number 06542921190 and lot number 422313 on the test kit.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide distribution in the states of NJ, HI, IA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Hawaii, Iowa, New Jersey.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0679-2020 (October 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0679-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.