Recall Z-1127-2007

Instrumentation Laboratory Co. · initiated June 19, 2007

Terminated

Product

Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000

Codes / lots: Serial numbers prior to 07060782

Reason for recall

ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.

FDA-determined cause: Other

Action taken

Instrumentation Laboratory notiifed the distributor Beckman Coulter on 6/19/2007. Beckman Coulter notified their customers and provided a copy with the Instructions for Recovery Procedure on how to avoid contamination from probe leaks.

Details

Recall number
Z-1127-2007
Initiated
June 19, 2007
Posted by FDA
August 7, 2007
Terminated
May 23, 2012
Product code
GKP – Instrument, Coagulation, Automated
Quantity
94
Distribution
Nationwide.
Recalling firm
Instrumentation Laboratory Co., Lexington, MA

Official FDA recall record