← FDA ENFORCEMENT
Z-0162-2027Class III

Magellan Diagnostics, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Magellan Diagnostics, Inc.
Product type
Device
Status
Ongoing
Report date
2026-10-21
Distribution
US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.
Firm state
MA
Product quantity
321 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.

Product description

LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.

Code / lot info

Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.

Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →