Recall Z-1073-2013
Siemens Healthcare Diagnostics, Inc. · initiated March 11, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
Codes / lots: Catalog numbers B4219-1 and B4219-2: lot numbers 547311, exp 3/22/2013; 547312, exp 3/22/2013 and 547316A, exp 4/28/2013.
Reason for recall
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.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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.
Details
- Recall number
- Z-1073-2013
- Initiated
- March 11, 2013
- Posted by FDA
- April 9, 2013
- Terminated
- December 24, 2013
- Product code
- GGW – Test, Time, Partial Thromboplastin
- 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 Canada.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE