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LeadCare II Blood Lead Test Kit-For in vitro diagnostic use… recallZ-0219-2024 · Magellan Diagnostics, Inc. · initiated Sep 19, 2023

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Magellan Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

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).

FDA root cause category: Nonconforming Material/Component

What the company is doing

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

Recall details

Recall number
Z-0219-2024
Status
Open, Classified
Initiated by the company
Sep 19, 2023
Posted by the FDA
Nov 3, 2023
Recalling firm
Magellan Diagnostics, Inc.
Quantity
11,442 LeadCare II kits (549,216 tests)
Product code
DOF
FDA submissions
K052549
Distribution
US Nationwide distribution.

Product 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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

4 devices cleared under K052549 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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