Medical Device Recall: Z-0737-04

FDA Recalls dataset · Firm: Instrumentation Laboratory Co. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-03-04 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0737-04.

Recall Res Number
Z-0737-04
Recalling Firm / Manufacturer
FEI Number
1217183
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-03-04
Date Posted
2004-07-20
Date Terminated
2016-01-28
Product Code
JPA
Event Number
28485
Product Quantity
760 units
Product Description ACL Advance Instrument Analyzer

Reason for Recall Software may cause instrument to omit step causing reagent carrover which may effect patient test result

Action Details Instrumentation Laboratory (IL) notified the Distributor Beckman Coulter, FL by letter on 3/9/04. Beckman will notify customers of the mandatory software upgrade by letter dated 3/4/04 with instructions for the software installation.

Distribution Pattern Florida Canada

Code Information / Serial Numbers Software version prior to V2.1

Related Establishments / Registrations

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