LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Summary
The FDA issued a Class III for LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762. by Magellan Diagnostics, Inc.. 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.
Details
Source
Device Recall
External ID
Z-0162-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Lot/Code Info: Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.
Quantity Affected: 321 units
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.
Distribution
US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-04
Company
North Billerica, MA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
Magellan Diagnostics, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Magellan Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Magellan Diagnostics, Inc. have FDA actions?
Magellan Diagnostics, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0162-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29