Lower riskMedical device recall · FDA · Published November 6, 2020
Roche Tina-quant C-Reactive Protein Gen 3 Recall: Low Quality Recovery Risk
Roche recalls Tina-quant C-Reactive Protein Gen 3 (catalog 0517237:42402301) due to low quality recovery and invalid calibrations from cross contamination between reagents.
Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
Roche is recalling Tina-quant C-Reactive Protein Gen 3 test kits because they can cause inaccurate results due to cross contamination between reagents. This affects lab tests that measure CRP in blood samples. If you use these kits, your test results might be unreliable. Read more at govinfonow.com/recall/63978-roche-tina-quant-c-reactive-protein-gen-3-recall-low.
“Roche Tina-quant C-Reactive Protein Gen 3 Recall: Low Quality Recovery Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63978-roche-tina-quant-c-reactive-protein-gen-3-recall-low. Based on FDA recall #Z-0634-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0634-2021%22&limit=1).
Roche Diagnostics Operations, Inc. recalled Tina-quant C-Reactive Protein Gen.3 on Nov. 6, 2020, due to low quality recovery and invalid calibrations, the FDA said. The Food and Drug Administration announced the Class II recall of 699 units distributed nationwide.
How to tell if you have it
Brand: Roche
Product: Tina-quant C-Reactive Protein Gen.3
Catalog number: 05172373190
Lot code: CRPL3 - lot 42402301
The hazard
Roche confirmed customer complaints of low quality recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration, specifically a yellow color, was observed as the result of cross contamination between the R1 and R3 reagents.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has 32 other recalls on record since July 2, 2019. Recent similar recalls include the Roche cobas pro integrated solutions recall (Jan. 20, 2026), the Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and the Roche cobas HCYS Assay Recall (Oct. 17, 2024). Other recent recalls of similar products include the Siemens Atellica CH RCRP Test May Give False High Results (Aug. 17, 2026), the Siemens Dimension Creatinine Flex Reagent Cartridge Recall (March 18, 2026), and the Immunotech Estrone RIA Kit Recall (Dec. 15, 2025).
How to tell if you have this one
Check for the catalog number 05172373190 on the kit. The product was sold with CRPL3 lot 42402301. This kit is used for CRP testing on Roche cobas c701 or c702 analyzers.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for the catalog number 05172373190 and CRPL3 lot 42402301 on the kit label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 22 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of AL, CA, FL, GA, HI, IA, IL, IN, KY, MA, MD, MI, MN, MO, NJ, NY, OH, PA, SC, TN, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia.
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0634-2021 (November 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0634-2021 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.