CLASS II Device recall · Reported 23 Dec 2020 · FDA Enforcement Report
Tina-quant C-Reactive Protein Gen.3 recalled
Roche Diagnostics Operations is recalling Tina-quant C-Reactive Protein Gen.3, distributed nationwide in the US. The recall was initiated on 6 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0634-2021
- FDA event ID
- 86745
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Nov 2020
- FDA classified
- 17 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Nov 2020 | Recall initiated by company | |
| 17 Dec 2020 | Classified by FDA | +41 days |
| 23 Dec 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
Where it was distributed
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.
Nationwide AlabamaCaliforniaFloridaGeorgiaHawaiiIowaIllinoisIndianaKentuckyMassachusettsMarylandMichiganMinnesotaMissouriNew JerseyNew YorkOhioPennsylvaniaSouth CarolinaTennessee
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
CRPL3 - lot 42402301
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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