Recall Z-1073-2013 ยท GGW Test, Time, Partial Thromboplastin
Siemens Healthcare Diagnostics, Inc.
Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
| Date | Apr 9, 2013 (initiated Mar 11, 2013) |
| Status | Terminated |
| Reason | Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high. |
| Root cause | Unknown/Undetermined by firm |
| Action | Siemens sent an "URGENT FIELD SAFETY NOTICE" dated February 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The safety notice instructed consignees to discontinue use of the affected lots and discard any remaining inventory. Contact the firm at 1-800-242-3233, option 1 for questions about this notice. |
| Quantity | 13,083 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and Puerto Rico and the country of Ca |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K863594 | ACTIN FSL ACTIVATED PTT REAGENT American Dade, Oct 17, 1986 |