Recall Z-1927-2019 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Corporation
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
| Date | Jul 3, 2019 (initiated Apr 4, 2019) |
| Status | Terminated |
| Reason | There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument. |
| Root cause | Nonconforming Material/Component |
| Action | On April 4, 2019, Roche issued Urgent Medical Device Correction notices (UMDC TP-00620) to customers via UPS Ground (receipt required). Customers were advised to take the following actions: 1) Inspect the tray input flap on the cobas p 501 or p 701 post-analytical unit to determine if it is loose. If it is not fastened securely or becomes loose prior to the part being replaced, contact your Roche Field Engineer Specialist (FES) to repair the instrument. 2) Complete and return the fax form (TP-00621) via fax or email 3) File the UMDC for future reference. Customers with questions may cont |
| Quantity | 4 units |
| Distribution | US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.