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Terminated

ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762

FDA Recall Z-0042-2008 · Posted 2007-10-18

Recalling FirmEsa Biosciences, Inc.
Recall StatusTerminated
Product CodeDOF
Date Initiated2007-09-20
Date Terminated2008-03-25
Product Quantity365 kits

Reason for Recall

Level 1 and Level 2 Control values were incorrectly assigned.

Firm Action

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.

Root Cause

Process design

Distribution Pattern

Nationwide and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052549LEADCARE II BLOOD LEAD TESTING SYSTEMEsa Biosciences, Inc. · 2005-10-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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