Recall Z-1923-2015 ยท JFY Enzymatic Method, Creatinine
Roche Diagnostics Operations, Inc.
Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
| 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 | 6,255 analytical units distributed |
| Distribution | US (nationwide) including PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003261 | CREATININE PLUS Roche Diagnostics Corp., Nov 16, 2000 |