Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer
FDA device recall Z-2387-2012 · posted 2012-09-14 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- Reason for recall
- Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
- Action taken
- The firm, Instrumentation Laboratory, sent a "Mandatory Test Parameter Upgrade" letter dated June 7, 2012 with upgrade kits P-14.8 via USPS on August 3 thru August 10 to US and Canadian customers and notified International Affiliates via e-mail on August 2, 2012. The customers were ask to complete and return the Mandatory Test Parameter Upgrade Tracking Form via fax: 781-861-4207 or email: ra-usa@ilww.com. If you have any questions, call 781-861-4204.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKP
- Quantity affected
- 1074 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG K
- Date initiated
- 2012-08-03
- Date posted
- 2012-09-14
- Date terminated
- 2015-10-02
- 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 |