Recall Z-2944-2018 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Corporation
Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for use with analyzers that perform tests in the area of clinical chemistry, immuno chemistry, coagulation, hematology, urinalys
| Date | Jul 16, 2018 |
| Status | Terminated |
| Reason | Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter tips. The possible presence of biological material on the nozzle may cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology. |
| Root cause | Under Investigation by firm |
| Action | The firm, Roche, issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated 7/6/18 to its customers on 7/6/18. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: Complete all sections of the enclosed faxback form and fax it to number 1-866-469-2231 or email it to Roche6840@stericycle.com. " Ensure you have at least a two-week supply of disposable filter tips before the Roche FES arrives to modify your system. " Provide copies of this Urgent Medical Device Correction (UMDC) to other clinicians who may need to be aware of this is |
| Quantity | 12 units |
| Distribution | US Distribution to states of: CA, NY,TX, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.