CLASS II Device recall · Reported 25 Nov 2015 · FDA Enforcement Report
Bulk Loader Module for cobas p 512/612 Pre-analytical recalled
Roche Diagnostics Operations is recalling Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes, distributed in Texas. The recall was initiated on 22 Sep 2015 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-0297-2016
- FDA event ID
- 72427
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2015
- FDA classified
- 18 Nov 2015
- Reported
- 25 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Sep 2015 | Recall initiated by company | |
| 18 Nov 2015 | Classified by FDA | +57 days |
| 25 Nov 2015 | 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
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
Product as listed by the FDA
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
Where it was distributed
Distributed to TX only.
Questions about this recall
Is Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes recalled?
Yes. Roche Diagnostics Operations recalled Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes on 22 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-0297-2016.
Why was it recalled?
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
Which lots are affected?
During transport from the Bulk Loader Module (BLM), catalog number 07135645001, to the cobas p 512/p 612 pre-analytical instruments, sample tubes may inadvertently open and spill, causing contamination of the system.
Where was it sold?
Distributed to TX only.
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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