CLASS II Device recall · Reported 16 Oct 2019 · FDA Enforcement Report
cobas c 311; cobas c 501, 502,and Cobas Integra 400 plus recalled
Roche Diagnostics Operations is recalling cobas c 311; cobas c 501, 502,and Cobas Integra 400 plus Analyzer/Module-RF interference, distributed nationwide in the US. The recall was initiated on 28 Aug 2019 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-0108-2020
- FDA event ID
- 83758
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2019
- FDA classified
- 9 Oct 2019
- Reported
- 16 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 28 Aug 2019 | Recall initiated by company | |
| 9 Oct 2019 | Classified by FDA | +42 days |
| 16 Oct 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
Where it was distributed
Nationwide
Questions about this recall
Is cobas c 311; cobas c 501, 502,and Cobas Integra 400 plus Analyzer/Module-RF interference recalled?
Yes. Roche Diagnostics Operations recalled cobas c 311; cobas c 501, 502,and Cobas Integra 400 plus Analyzer/Module-RF interference on 28 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-0108-2020.
Why was it recalled?
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
Which lots are affected?
All serial numbers
Where was it sold?
Nationwide
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Roche Diagnostics Operations
All 127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | cobas pro integrated solutions recalled by Roche Diagnostics Operations | Roche Diagnostics Operations | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | The Elecsys Anti-TSHR immunoassay is a three-step recalled | Roche Diagnostics Operations | Particulate Matter | Nationwide |
| Device | CLASS II | cobas HCYS, Homocysteine Enzymatic Assay, Material Number recalled | Roche Diagnostics Operations | Potency & Assay | 8 states |
| Device | CLASS II | Creatine Kinase (CK) used on cobas c 311/501/502 recalled | Roche Diagnostics Operations | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Tina-quant D-Dimer Test System recalled by Roche Diagnostics Operations | Roche Diagnostics Operations | Potency & Assay | Nationwide |
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