Recall Z-1043-2012 ยท GGW Test, Time, Partial Thromboplastin
Siemens Healthcare Diagnostics, Inc.
Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage: Liquid purified soy and rabbit brain phosphatides with plasma activator. An activated partial thromboplastin reagent with increased sensitivity to lupus-like inhibitors for use in the determination of the activated partial thromboplastin time (APTT) and related coagulation procedures.
| Date | Feb 16, 2012 (initiated Dec 19, 2011) |
| Status | Terminated |
| Reason | The listed lots of Dade(R) Actin(R) FSL Reagent 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 letter dated December 2011 to all customers of the affected lots. The letter identified the product, description of problem, and actions to be taken by the user. Dade Actin FSL customers were instructed to exercise one of two options: 1) If customers would like to continue working with their Dade(R) Actin FSL reagent lot (if one of the impacted lots) they must verify on a regular basis (monthly) that their therapeutic range is still valid, e.g. by using a Heparin containing control. In the case that it is not valid, they are to adjust their existin |
| Quantity | 24,672 Kits |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of Australia, Austria, B |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K863594 | ACTIN FSL ACTIVATED PTT REAGENT American Dade, Oct 17, 1986 |