Recall Z-1929-2015 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Operations, Inc.
Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems.
| Date | Jun 27, 2015 (initiated May 7, 2015) |
| Status | Terminated |
| Reason | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| Root cause | Under Investigation by firm |
| Action | Roche Diagnostics initiated a voluntary recall and the Urgent Medical Device Correction notices were sent via UPS Ground on 05/07/2015 to customers. Customers were notified of the interference and the method sheets and package inserts will be updated with the new interference claims. The firm plans to monitor any non-responding accounts and address those customers with follow-up attempts to distribute recall notices. The firm plans to conduct level B effectiveness checks via fax and phone. Until the new method sheets are available, the Urgent Medical Device Correction serves as the updated |
| Quantity | 6255 |
| Distribution | US (nationwide) including PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K921661 | BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER Boehringer Mannheim Corp., Jun 30, 1992 |