Recall Z-0138-2011 ยท GKP Instrument, Coagulation, Automated
Instrumentation Laboratory Co.
ACL TOP CTS PN 000280020 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 | Oct 25, 2010 (initiated Aug 13, 2010) |
| Status | Terminated |
| Reason | Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves |
| Root cause | Software design |
| Action | Instrumentaion Laboratory notified the US Distributor/Canada via BCI Service Modification Notice (#10793) on August 13, 2010. The Mandatory software upgrade to Verison V4.3.0 in the United States and Canada will be conducted by BCI service representatives and tracked through the distributor, Beckman Coulter (BCI). International Affiliates/Dealers: Worldwide Regulatory Notices were e-mailed to IL international affiliates and dealers, notifying them of the mandatory software upgrade, providing issue description and a risk summary and the support. The upgrades were to be handled through the loca |
| Quantity | 609 units |
| Distribution | Worldwide Distribution, USA and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091980 | ACL TOP 700 LAS Instrumentation Laboratory CO, Sep 22, 2009 |