Device product
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Z-1927-2019
Product summary
- Event
- Event 82651
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1927-2019
Official wording
Reason: There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
Code information: Serial Numbers - 1001 through 1044
Distribution pattern: US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA
Derived failure modes
-
Unknown
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.