FDA Device Recall Z-0378-06: Instrumentation Laboratory Co.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0378-06.

Recall Res Number

Z-0378-06

Recalling Firm / Manufacturer

Instrumentation Laboratory Co.

FEI Number

1217183

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-12-16

Date Posted

2006-01-11

Date Terminated

2007-05-21

Product Code

CGA

Event Number

34249

Product Quantity

2021 units

Product Description GEM PREMIER 3000

Reason for Recall Software error may report higher results for glucose and lactate

Action Details Instrumentation Laboratory notified customers by letter dated December 2005 on 12/16/2005. Customers were notifed if the error message occurs the lab should diable the glucose and lactate channels or remove cartridge. A software upgrade will be released in early 2006.

Distribution Pattern Nationwide Foreign: Canada

Code Information / Serial Numbers Serial numbers starting with 18412

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Medical Device Recall: Z-0378-06

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer