Blood Lead Test Kits Recalled for Defective Treatment Reagent Caps
Magellan Diagnostics recalls LeadCare II Blood Lead Test Kits nationwide due to defective plastic caps on reagent tubes. A small percentage of caps may not seal properly, potentially leading to inaccurate test results.
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: This is a Class II medical device recall with no reported illnesses or injuries. The defect creates a risk of inaccurate diagnostic results through inadequate seals on reagent tube caps, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Magellan Diagnostics, Inc. is recalling 11,442 LeadCare II Blood Lead Test Kits (549,216 tests) distributed nationwide. The test kits are used for in vitro diagnostic measurement of lead in capillary whole blood.
During an internal audit, the manufacturer identified that a small percentage (less than 10 percent) of the plastic caps used to seal treatment reagent tubes do not meet minimum dimensional requirements. These defective caps may form inadequate seals.
Inadequate cap seals may allow leaking of hydrochloric acid or evaporation of the treatment reagent. Either condition changes the volume and concentration of the reagent, altering the ratio of patient sample or control material to reagent. This can result in falsely elevated test results, including false positive readings or out-of-range control results.
Healthcare providers and laboratories using the affected lot numbers should discontinue use and contact Magellan Diagnostics for replacement or further instructions.
The recalled product
- Product
- LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
- Manufacturer
- Magellan Diagnostics, Inc.
- Hazard
- seal-failure
- test-inaccuracy
- false-positive
Distribution
Distributed nationwide across the United States.
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