Recall Z-2060-2014 ยท GKP Instrument, Coagulation, Automated
Instrumentation Laboratory Co.
ACL TOP (Base), automated coagulation laboratory instrument.
| Date | Jul 16, 2014 (initiated Jun 3, 2014) |
| Status | Terminated |
| Reason | Potential for sample misidentification. |
| Root cause | Device Design |
| Action | Consignees were notified via phone starting on June 3, 2014. On June 4, a USPS mailing was sent to all US/Canadian customers. On June 4, 2014, email notifications were sent to the IL Affiliates and International Distributors/Dealers (through the International Group) requesting them to translate the Field Safety Notice and provide notification to their customer base and secondary distributors. The Urgent Product Correction letter informs consignees of the issue and provides workaround instructions. Consignees are asked to complete a Mandatory Response Tracking Record and return it via Fax (7 |
| Quantity | 1074 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of 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, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argent |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091980 | ACL TOP 700 LAS Instrumentation Laboratory CO, Sep 22, 2009 |