CLASS II ONGOING Device recall · Reported 6 Jan 2021 · FDA Enforcement Report
Roche cobas pro integrated solutions (cobas pro ISE recalled
Roche Diagnostics Operations is recalling Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801, distributed nationwide in the US. The recall was initiated on 8 Dec 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-0755-2021
- FDA event ID
- 86981
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Dec 2020
- FDA classified
- 30 Dec 2020
- Reported
- 6 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 8 Dec 2020 | Recall initiated by company | |
| 30 Dec 2020 | Classified by FDA | +22 days |
| 6 Jan 2021 | 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
Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.
Product as listed by the FDA
Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 recalled?
Yes. Roche Diagnostics Operations recalled Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 on 8 Dec 2020. The recall is Class II and its status is Ongoing. Recall number Z-0755-2021.
Why was it recalled?
Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.
Which lots are affected?
Serial Numbers: 1925-10; 1931-04; 1931-05;1931-07;1937-10; 1938-01; 1942-10
Where was it sold?
US Nationwide distribution.
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
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|---|---|---|---|---|---|
| Device | CLASS II | cobas pro integrated solutions recalled by Roche Diagnostics Operations | Roche Diagnostics Operations | Lead & Heavy Metals | Nationwide |
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