Recall Z-0302-2017 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
TEM Systems Inc
ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
| Date | Sep 13, 2016 |
| Status | Terminated |
| Reason | Customers complained of low/empty reagent vials. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were notified of the recall by an Urgent Important Customer Information letter on 9/13/2016. The letter described the device and the problem. Customers were told to stop using the product and to call for replacement product. The letter included a Confirmation of Compliance Letter which was to be completed and returned. |
| Quantity | 637 boxes x 10 vials |
| Distribution | Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101533 | EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM Tem Innovations GmbH, Aug 10, 2011 |