Medical Device Recall: Z-0032-06

FDA Recalls dataset · Firm: BIOMERIEUX, INC. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2005-08-19 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0032-06.

Recall Res Number
Z-0032-06
Recalling Firm / Manufacturer
FEI Number
3002769706
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2005-08-19
Date Posted
2005-10-22
Date Terminated
2006-10-16
Product Code
JPA
Event Number
33440
Product Quantity
2334 kits
Product Description VeriCal Calibrator Set

Reason for Recall The product is being recalled due to mis-assignment of ISI values associated with VeriCal use.

Action Details Consignees were notified on/about 08/31/2005.

Distribution Pattern Nationwide

Code Information / Serial Numbers Lots 161813, 161907, 161908, 161909

Related Establishments / Registrations

Public Record Disclaimer

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.

Account Required Full available specs will require a free AvaSpecs account.