ACL TOP 700 LAS PN 000280030 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.
Recall
- Recall Number
- Z-0137-2011
- Event Number
- 56657
- Firm
- Instrumentation Laboratory Co.
- FEI Number
- 1217183
- Product Code
- GKP
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- August 13, 2010
- Posted
- October 25, 2010
- Terminated
- May 23, 2012
- Address
- 180 Hartwell Road, Bedford, MA, 01730-2443
Description
ACL TOP 700 LAS PN 000280030 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.
Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves
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 local representatives.
Worldwide Distribution, USA and Canada
5 units