ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagno
FDA device recall Z-0135-2011 · posted 2010-10-25 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- Reason for recall
- Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKP
- Quantity affected
- 177 units
- Distribution
- Worldwide Distribution, USA and Canada
- Date initiated
- 2010-08-13
- Date posted
- 2010-10-25
- Date terminated
- 2012-05-23
- Location
- Bedford, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACL TOP 700 LAS (K091980) | Instrumentation Laboratory CO | 2009-09-22 |