Medical Device Recall: Z-0042-2008

FDA Recalls dataset · Firm: Esa Biosciences, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2007-09-20 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0042-2008.

Recall Res Number
Z-0042-2008
Recalling Firm / Manufacturer
Esa Biosciences, Inc.
FEI Number
1218996
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2007-09-20
Date Posted
2007-10-18
Date Terminated
2008-03-25
Product Code
DOF
Event Number
44909
Product Quantity
365 kits
Product Description ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762
Reason for Recall Level 1 and Level 2 Control values were incorrectly assigned.
Action Details ESA notifed Distributors and End Users by telephone and letter on 9/20/07. Distributors and End Users will be informed of the Level 1 and 2 Control value assignment change. End Users will be sent a new Level 1 and 2 Control Vial label for each vial they originally received. Distributors will be asked to return all test kits in their inventory to ESA Biosciences.
Distribution Pattern Nationwide and United Kingdom.
Code Information / Serial Numbers Lot number: 0704A

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.