Recall Z-1633-2016 ยท NRP Sirolimus Test System
Siemens Healthcare Diagnostics, Inc.
Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.
| Date | Feb 9, 2016 |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days. |
| Root cause | Under Investigation by firm |
| Action | Siemens sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer: Discontinue use of and discard the kit lot listed in Table 1. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your |
| Quantity | 394 |
| Distribution | Worldwide distribution and US including Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081857 | DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 Siemens Healthcare Diagnostics, Inc., Oct 30, 2008 |