Z-0914-05

LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233

Name: Z-0914-05 LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233
Creator: Esa Biosciences, Inc.
Published: 2005-05-19
License: https://open.fda.gov/license/

Magellan Diagnostics, Inc. / initiated 2005-05-19 / Terminated

FDA source

Esa Biosciences, Inc. began a recall of LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233 on 2005-05-19. The reason FDA records is "Lead test results may be reported lower than the actual value". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0914-05
Status: Terminated
Initiated: 2005-05-19
Posted: 2005-06-21
Terminated: 2005-11-21
Recalling firm: Magellan Diagnostics, Inc.
Product: LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233
Product code: DOF Lead, Atomic Absorption
Reason for recall: Lead test results may be reported lower than the actual value
FDA root cause: Other
Action: ESA is notifying beginning 5/19/05 to Distributors and End Users by letter sent First Class Mail. Additionally Distributors may be notified by phone to ensure receipt of letter. Customers will be asked to return product to ESA for destruction. A fax back form is included with the notification letter. Customers will fax back the number of Test Kits that they require replacement for. ESA will ship replacement kits and include a prepaid return shipping label for the customer to return defective kits to ESA.
Quantity in commerce: 14,760 test kits
Distribution: United States Foreign: Mexico, Canada, Indonesia, Palestine, Kingdom of Saudi Arabia, Columbia, Switzerland, Romania, West Indies, Italy, Japan, Turkey, United Kingdom, Phillipines, Singapore, Jamaica, Uraguay, South Korea, Peru, Tanzia, South Africa, Quatar, Croatia, Zambia, China, Germany
Product codes and lots: Lot CA6 Expiration date 2/5/05 Lot CA7 Expiration date 2/06/05 Lot CA8 Expiration date 5/18/05 Lot CA9 Expiration date 10/5/05 Lot CCA Expiration date 12/11/05 Lot CCE Expiration date 6/17/06 Lot CCF Expiration date 7/11/06 Lot CCH Expiration date 7/12/06

Product code DOF

K971640Class IILeadcare Blood Lead Testing SystemEsa, Inc. / cleared 1997-09-09

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)