Recall Z-1927-2019— Roche Diagnostics Corporation
Class III · Terminated
Class III FDA medical device recall by Roche Diagnostics Corporation, initiated 2019-04-04, terminated 2020-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.. Reason: There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument..
- Recalling firm
- Roche Diagnostics Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-04-04
- Terminated
- 2020-05-12
- Firm location
- Indianapolis, IN, United States
Product description
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Reason for recall
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
Data sourced from openFDA. This site is unofficial and independent of the FDA.