Recall Z-0162-2027— Magellan Diagnostics, Inc.

Name: FDA recall Z-0162-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-04

Class III · Ongoing

Class III FDA medical device recall by Magellan Diagnostics, Inc., initiated 2026-09-04. It names one FDA 510(k) clearance: K052549. Product: LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.. Reason: 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..

Recalling firm: Magellan Diagnostics, Inc.
Classification: Class III
Status: Ongoing
Initiated: 2026-09-04
Firm location: North Billerica, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K052549 — LEADCARE II BLOOD LEAD TESTING SYSTEMEsa Biosciences, Inc.·cleared 2005-10-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.