Lower riskMedical device recall · FDA · Published August 15, 2024
Roche CK Test Recalls: Erroneous Results Risk from Calibration Issues
Roche recalls CK tests for cobas c 311/501/502 and COBAS INTEGRA 400 plus analyzers due to potential calibration errors causing misdiagnosis. Affected lots expire June 2024.
Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.
“Roche CK Test Recalls: Erroneous Results Risk from Calibration Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54232-roche-ck-test-recalls-erroneous-results-risk-from-calibration-issues. Based on FDA recall #Z-3187-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3187-2024%22&limit=1).
Roche Diagnostics Operations, Inc. recalled Creatine Kinase (CK) in vitro tests on Aug. 15, 2024, according to the FDA. Abnormal calibrations may lead to erroneous results and misdiagnosis.
How to tell if you have it
Brand: Roche
Product: Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus
Catalog Number: 07190794190
Lot Number: 755471
Expiration Date: 06/30/2024
The hazard
Abnormal calibrations on the cobas c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has had 32 other recalls since July 2, 2019. Other recent recalls of similar products include Roche cobas pro integrated solutions (Jan. 20, 2026), Roche Elecsys Anti-TSHR Assay (Nov. 21, 2025), and Roche cobas HCYS Assay (Oct. 17, 2024). Other recent recalls of similar products include Siemens Dimension Creatinine Flex Reagent Cartridge (March 18, 2026), Siemens Atellica CH Urine Albumin (July 6, 2026), and Biomerieux VITEK 2 AST-N461 Test Kit (July 24, 2026).
How to tell if you have this one
Check for the catalog number 07190794190 or UDI-DI 04015630940806 on the test kit. The lot number 755471 with an expiration date of June 30, 2024, is also specific to this recall.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Test Kit Details
Look for the catalog number 07190794190 or UDI-DI 04015630940806 on the test kit.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 48 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-3187-2024 (August 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3187-2024 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.