Recall Z-2392-2012 ยท GKP Instrument, Coagulation, Automated
Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a 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 14, 2012 (initiated Aug 3, 2012) |
| Status | Terminated |
| Reason | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low |
| Root cause | Software design |
| Action | The firm, Instrumentation Laboratory, sent a "Mandatory Test Parameter Upgrade" letter dated June 7, 2012 with upgrade kits P-14.8 via USPS on August 3 thru August 10 to US and Canadian customers and notified International Affiliates via e-mail on August 2, 2012. The customers were ask to complete and return the Mandatory Test Parameter Upgrade Tracking Form via fax: 781-861-4207 or email: ra-usa@ilww.com. If you have any questions, call 781-861-4204. |
| Quantity | 140 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091980 | ACL TOP 700 LAS Instrumentation Laboratory CO, Sep 22, 2009 |