Recall Z-2244-2013 ยท GKP Instrument, Coagulation, Automated
Instrumentation Laboratory Co.
ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
| Date | Sep 18, 2013 (initiated Jul 19, 2013) |
| Status | Terminated |
| Reason | Potential carryover issue that can can cause shortened APTT clotting times on the instrument. |
| Root cause | Device Design |
| Action | Instrumentation Laboratory sent an Important Product Correction letter on July 19, 2013, to all affected customers. On July 23, 2013, the same communication was circulated by the IL International Group in Milan, Italy to the affected international distributors and dealers. The interim field notification was followed by the release of corrective Software V5.1.0 and Parameters P-16.3.00 (Phase II) on September 30,2013. Consignees were advised of a potential carryover issue and a workaround was provided. Consignees were asked to fax the Mandatory Response Tracking Form to 781-861-4207 or emai |
| Quantity | 929 |
| Distribution | Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belg |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091980 | ACL TOP 700 LAS Instrumentation Laboratory CO, Sep 22, 2009 |