ESA LeadCare II Blood Test Kit containing Level 1 and Level… recallZ-0042-2008 · Esa Biosciences, Inc. · initiated Sep 20, 2007
Terminated All recalls posted in October 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Esa Biosciences, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Level 1 and Level 2 Control values were incorrectly assigned.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-0042-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 20, 2007
- Posted by the FDA
- Oct 18, 2007
- Recalling firm
- Esa Biosciences, Inc.
- Quantity
- 365 kits
- Product code
- DOF
- FDA submissions
- K052549
- Distribution
- Nationwide and United Kingdom.
Product description
ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762
Code information (models, lots, serial numbers)
Lot number: 0704A
Other devices under the same FDA submission
5 devices cleared under K052549 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LeadCare® II Blood Lead Test KitMagellan Diagnostics, Inc. · Lead, Atomic Absorption4 recalls353 reports
- LeadCare® II Blood Lead Analyzer KitMagellan Diagnostics, Inc. · Lead, Atomic Absorption137 reports
- LeadCare® II 5X Test KitMagellan Diagnostics, Inc. · Lead, Atomic Absorption1 recall0 reports
- LeadCare® II Blood Lead Testing System 9X Test KitMagellan Diagnostics, Inc. · Lead, Atomic Absorption1 recall0 reports
- LeadCare® II Blood Lead Analyzer Kit, RefurbishedMagellan Diagnostics, Inc. · Lead, Atomic Absorption21 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 44909).
- Z-0043-2008 · TerminatedESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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