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.
Cross contamination between the R1 and R3 reagents causes yellow discoloration and leads to low quality recovery and invalid calibrations. This means test results for CRP (a blood marker) may be inaccurate.
Lab users who test blood samples with the Tina-quant C-Reactive Protein Gen 3 kits are affected. Those using the kits on Roche cobas c701 or c702 analyzers are most at risk.
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.
Look for the catalog number 05172373190 and CRPL3 lot 42402301 on the kit label.
Roche confirmed customer complaints of low quality recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen 3 on cobas c701 and c702 analyzers due to cross contamination between reagents.
The test results for CRP (a blood marker) may be inaccurate because of cross contamination between reagents.
Check for the catalog number 05172373190 and CRPL3 lot 42402301 on the kit label.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0634-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-0634-2021 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
