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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI :(01)00850355006000 Lot Numbers: 2231 2231-10 2303M-11 2303M-12 2303M-13 2303M-15 2305M-01 2305M-02 2305M-03 2305M-04 2305M-05 2306M-01 2306M-02 2306M-03 2306M-04 2306M-05 2306M-06 2307M 2307M-04 2307M-05 2307M-06 2307M-07 2307M-10 2307M-11 2308M-01 2308M-02 2308M-03 2308M-07 2309M 2310M-01 2310M-03 2310M-04 2310M-05 2310M-06 2310M-08 2311M-02 2311M-03 2311M-05 2311M-09 2311M-10 2312M 2312M-01 2312M-04 2312M-05 2312M-07 2313M 2313M-01 2313M-05 2313M-07 2314M-06 2314M-07 2314M-08 2314M-09 2314M-12 2314M-13 2315M-02 2315M-03 2315M-04 2315M-05 2315M-06 2315M-07 2315M-08 2315M-13 2316M 2316M-03 2316M-04 2316M-05 2316M-06 2316M-11 2316M-12 2317M 2317M-01 2318M 2320M-06 7308M
- 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:
- 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).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
UDI-DI :(01)00850355006000 Lot Numbers: 2231 2231-10 2303M-11 2303M-12 2303M-13 2303M-15 2305M-01 2305M-02 2305M-03 2305M-04 2305M-05 2306M-01 2306M-02 2306M-03 2306M-04 2306M-05 2306M-06 2307M 2307M-04 2307M-05 2307M-06 2307M-07 2307M-10 2307M-11 2308M-01 2308M-02 2308M-03 2308M-07 2309M 2310M-01 2310M-03 2310M-04 2310M-05 2310M-06 2310M-08 2311M-02 2311M-03 2311M-05 2311M-09 2311M-10 2312M 2312M-01 2312M-04 2312M-05 2312M-07 2313M 2313M-01 2313M-05 2313M-07 2314M-06 2314M-07 2314M-08 2314M-09 2314M-12 2314M-13 2315M-02 2315M-03 2315M-04 2315M-05 2315M-06 2315M-07 2315M-08 2315M-13 2316M 2316M-03 2316M-04 2316M-05 2316M-06 2316M-11 2316M-12 2317M 2317M-01 2318M 2320M-06 7308M
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0219-2024
Related Recalls
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.