CLASS II Device recall · Reported 2 Nov 2016 · FDA Enforcement Report
cobas p 501 Post-Analytical Unit calculator/data processing recalled
Roche Diagnostics Operations is recalling cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use, distributed nationwide in the US. The recall was initiated on 15 Jul 2016 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-0102-2017
- FDA event ID
- 75186
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jul 2016
- FDA classified
- 25 Oct 2016
- Reported
- 2 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Jul 2016 | Recall initiated by company | |
| 25 Oct 2016 | Classified by FDA | +102 days |
| 2 Nov 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
Product as listed by the FDA
cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR SYSTEMS analyzers.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use recalled?
Yes. Roche Diagnostics Operations recalled cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use on 15 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-0102-2017.
Why was it recalled?
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
Which lots are affected?
Not applicable
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.
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