Blood Lead Test Kit Recalled for Inaccurate Control Test Results
Magellan Diagnostics recalls LeadCare Plus Blood Lead Test Kit after control tests generated low results, potentially underestimating patient blood lead levels. Affected lot numbers include 2011MU, 2104MU, and 2108MU.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classification of Class I mandates a minimum severity score of 4. The recall involves control test malfunction that may cause underestimation of blood lead levels in patient samples, though no reported illnesses or injuries are mentioned in the source text.
Plain-English summary
Magellan Diagnostics, Inc. is recalling the LeadCare Plus Blood Lead Test Kit (Catalog Number 82-0004). This is a medical device used to measure blood lead levels in patient samples.
Reports indicate that control tests (low-control and/or high-control) within affected kits have generated low results. This malfunction may cause the kit to underestimate blood lead levels in patient samples, creating a risk of diagnostic inaccuracy.
The affected kits have been distributed worldwide, including throughout the United States and Puerto Rico, as well as to Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and the Philippines. The affected lot numbers are: 2011MU (expires 25 March 2022), 2104MU (expires 25 August 2022), and 2108MU (expires 31 March 2022). A total of 320 kits containing 96 tests per kit were distributed.
The recalled product
- Product
- LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
- Manufacturer
- Magellan Diagnostics, Inc.
- Category
- Medical Device
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 (1)
- 2108MU - 31MAR22.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Magellan Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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