The LeadCare¿ II Blood Lead Test System relies on recall: Labeling Error
The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is…
Why was The LeadCare¿ II Blood Lead Test System relies on recalled?
Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Name: LeadCare¿ II Blood Lead Test Kit; Catalog Number: 70-6762; Impacted Lot/Sublot Numbers: 2333M, 2333M-01, 2333M-02, 2333M-03, 2333M-04, 2333M-05, 2333M-06, 2333M-07, 2333M-08, 2333M-09, 2333M-10, 2333M-11; Device Identifier: (01)00850355006000;
- Product
- The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is…
- Recalling firm
- Magellan Diagnostics, Inc.
- Quantity
- 1,774 units
- Distribution
- US Nationwide distribution.
- Recall date
- December 3, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)