ACL TOP 500 CTS PN 000280040 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.
This recall has been terminated (originally issued October 25, 2010).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- August 13, 2010
- Posted
- October 25, 2010
- Terminated
- May 23, 2012
- Recall Number
- Z-0136-2011
- Quantity
- 285 units
- Firm Location
- Bedford, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves
Distribution
Worldwide Distribution, USA and Canada
Lot / Code Info
Serial Number range: 08010100-10061231
Root Cause
Software design
Action Taken
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.