LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Number: 82-0001. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Magellan Diagnostics, Inc.
- Reason for Recall:
- The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
Product Codes/Lot Numbers:
Part Number: 82-0001. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1296-2018
Related Recalls
Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
Magellan Diagnostics
During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely elevated result (e.g., a patient false positive [PATFP] result or a Controls Out of Range-High [COOR-Hi] result).
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Magellan Diagnostics
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.