Z-0219-2024Class II

LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative...

Name: Z-0219-2024 LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative...
Creator: Magellan Diagnostics, Inc.
Published: 2023-09-19
License: https://open.fda.gov/license/

Magellan Diagnostics, Inc. / initiated 2023-09-19 / Open, Classified / root cause: manufacturing process

FDA source

Magellan Diagnostics, Inc. began a recall of 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 on 2023-09-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0219-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-19
Posted: 2023-11-03
Recalling firm: Magellan Diagnostics, Inc.
Product: 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 code: DOF Lead, Atomic Absorption
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).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Magellan notified distributors/end users. Distributors initially contacted 19 September 2023 and told they would receive additional contacts from Magellan related to the recall and requests for a formal response. All distributors contacted by phone and provided the Recall Response forms included in the Recall Notification Letters. Hard copy recall notification letters issued via mail on Sept. 22, 2023. Distributors requested to provide customer lists and notifications will be carried out to the user level. Distributors will be permitted to continue distribution of impacted product, and users will be instructed to continue to use impacted product; however, replacement product will be provided upon request or if a consignee complains of PATFP or COOR-Hi results. The recall letter states reason for recall, health risk and action to take: Review current inventory and identify any remaining unexpired stock impacted by this recall: MAGELLAN WILL REPLACE IMPACTED PRODUCT UPON REQUEST; HOWEVER,YOU MAY CONTINUE TO USE ANY REMAINING UNEXPIRED STOCK. Continue to monitor impacted product for Controls Out of Range-High (COOR-Hi) results. If after following instructions in the LeadCare II Users Guide the control value is still out of range, please contact Magellan Technical Support. If you observe an elevated blood lead result on a patient, the test results should be shared with the patients physician for interpretation and to determine when retesting and follow-up care are necessary. If you identify a PATFP or a COOR-Hi result, you can contact Magellan Technical Support at 1-800-275-0102 to obtain a FedEx label to return any product to Magellan Diagnostics, Inc. and receive replacement product. Product will be replaced based on availability, and on a first-come first-served basis. NO ADDITIONAL ACTION IS REQUIRED: It is the recommendation of the Centers for Disease Control and Prevention (CDC) that if an initial blood lead screening is above the Blood Lead Reference Valu
Quantity in commerce: 11,442 LeadCare II kits (549,216 tests)
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0219-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0219-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03

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)