[pending] The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lea
Pending LLM rewrite. Source: FDA_DEVICE Z-0584-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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 provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packag
- Manufacturer
- Magellan Diagnostics, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
Distribution
Distributed nationwide across the United States.
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