Medical Device Recall: Z-0043-05

FDA Recalls dataset · Firm: bioMerieux · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-06-11 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0043-05.

Recall Res Number
Z-0043-05
Recalling Firm / Manufacturer
FEI Number
3002769706
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-06-11
Date Posted
2004-10-23
Date Terminated
2005-06-07
Product Code
JPA
Event Number
30026
Product Quantity
N/A
Product Description The MDA system with MDA Antithrombin III MDA Heparin

Reason for Recall The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens.

Action Details Consignees were initially notified by letter on June 11, 2004. A follow up letter was sent to consignees, via Fedex on July 9, 2004.

Distribution Pattern Nationwide, Australia, Belgium, Brazil, Canada, China, Germany, Italy, Japan, Taiwan, UK

Code Information / Serial Numbers All product numbers

Related Establishments / Registrations

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

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