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Terminated

Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).

FDA Recall Z-1073-2013 · Posted 2013-04-09

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeGGW
Date Initiated2013-03-11
Date Terminated2013-12-24
Product Quantity13,083

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.

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.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K863594ACTIN FSL ACTIVATED PTT REAGENTAmerican Dade · 1986-10-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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