Recall Z-0138-2011
Instrumentation Laboratory Co. · initiated August 13, 2010
Product
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.
Codes / lots: Serial Number range: 06020101-10030659
Reason for recall
Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves
FDA-determined 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.
Details
- Recall number
- Z-0138-2011
- Initiated
- August 13, 2010
- Posted by FDA
- October 25, 2010
- Terminated
- May 23, 2012
- Product code
- GKP – Instrument, Coagulation, Automated
- Quantity
- 609 units
- Distribution
- Worldwide Distribution, USA and Canada
- Recalling firm
- Instrumentation Laboratory Co., Bedford, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0135-2011 | ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed…Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot… | 08/13/2010Terminated |
| Z-0136-2011 | ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed…Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot… | 08/13/2010Terminated |
| Z-0137-2011 | ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed…Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot… | 08/13/2010Terminated |