Magellan Diagnostics, Inc.: 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.

Recall number

Z-0219-2024

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.

Status

Open, Classified

Initiated

2023-09-19

Posted

2023-11-03

Terminated

not on file

Reason

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

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

11,442 LeadCare II kits (549,216 tests)

Distribution

US Nationwide distribution.

Lot, serial or model codes

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

510(k) numbers

["K052549"]

PMA numbers

not on file

Product code

DOF

Firm FEI

1218996

Firm city

North Billerica

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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