Z-0043-2008

ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number...

Name: Z-0043-2008 ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number...
Creator: Esa Biosciences, Inc.
Published: 2007-09-20
License: https://open.fda.gov/license/

Magellan Diagnostics, Inc. / initiated 2007-09-20 / Terminated / root cause: manufacturing process

FDA source

Esa Biosciences, Inc. began a recall of ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142 on 2007-09-20. The reason FDA records is "Level 1 and Level 2 Control values were incorrectly assigned". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0043-2008
Status: Terminated
Initiated: 2007-09-20
Posted: 2007-10-18
Terminated: 2008-03-25
Recalling firm: Magellan Diagnostics, Inc.
Product: ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142
Product code: DOF Lead, Atomic Absorption
Reason for recall: Level 1 and Level 2 Control values were incorrectly assigned.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 2 kits
Distribution: Nationwide and United Kingdom.
Product codes and lots: Lot number: 0704A

Product code DOF

K052549Class IILeadcare II Blood Lead Testing SystemEsa Biosciences, Inc. / cleared 2005-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)