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LeadCare II Blood Lead Test Kit recallZ-1952-2021 · Magellan Diagnostics, Inc. · initiated May 7, 2021

Class I Terminated All recalls posted in July 2021

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

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On May 17, 2021, Magellan issued an Urgent Medical Device Removal notice to customers and distributors via letter notifying them Magellan has identified an ongoing issue with testing of the controls included in specified lots of LeadCareII Blood Lead Test Kits, LeadCare Plus Blood Lead Test Kits, and LeadCare Ultra Blood Lead Test Kits. REQUIRED ACTIONS: LeadCare blood lead test kits, Catalog Numbers: 70-6762, 82-0004, and 70-8098 - Per laboratory policies and procedures, laboratories should evaluate patient test results that were generated with the impacted lots. - Magellan is recommending retesting of suspect results below 5 mg/dL. - All blood Lead test results should be shared with the patient s physician for interpretation and to determine when retesting and follow-up care are necessary. - Review current inventory and segregate any remaining stock. - Discontinue use of any remaining stock. - Contact Magellan Technical Support 1-800-275-0102 to obtain a FedEx label to return any remaining inventory to Magellan Diagnostics, Inc. and receive replacement product (replacement product is currently available). - Promptly complete and return the Customer Notification Form (this will indicate receipt of this field correction notice). Complete this form even if you have no remaining inventory. On June 23, 2021, Magellan expanded their recall to include an additional product lot by placing telephone calls to the primary distributors. Magellan will issue an Expanded Urgent Medical Device Recall notice to all impacted customers via certified mail starting June 30,2021. Customers are advised to review inventory, segregate and discontinue use of all impacted products. Therefore, patient testing should not be performed (using any of the impacted lots) until resolution of the issue. Immediate Actions: - Review current inventory and segregate any remaining stock. - Discontinue use of any remaining stock. - Promptly complete and return the Customer Notification Form below t

Recall details

Recall number
Z-1952-2021
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
May 7, 2021
Posted by the FDA
Jul 1, 2021
Recalling firm
Magellan Diagnostics, Inc.
Quantity
387,281 kits (48 tests/kit=1,757,040 tests)
Product code
DOF
FDA submissions
K052549
Distribution
Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.

Product description

LeadCare II Blood Lead Test Kit Catalog Number 70-6762

Code information (models, lots, serial numbers)

Lot Numbers/Expiration Date: 2013M - 22APR22; 2014M - 29APR22; 2015M - 12MAY22; 2016M - 19MAY22; 2017M - 10JUN22; 1st expansion 6/21/2021: 2101M - 28JUL22; 2103M - 18AUG22; 2105M - 11SEP22; 2106M - 21JAN22; 2107M - 30SEP22; 2nd expansion 8/30/2021; 2012M Sublots: -08, -09, -10, -11, -12, -13, -14 - 08APR22; 2018M - 06JUN22; 2102M - 30SEP21; 2109M - 15OCT22; 2110M - 29OCT22; 2111M - 31MAY22; 2112M - 13NOV22; 2113M - 30JUN22; 2114M - 17DEC22; 2115M - 29DEC22; 7114M - 17DEC22.

Other devices under the same FDA submission

5 devices cleared under K052549 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 87992).

Sources and updates

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