Magellan LeadCare II Blood Lead Test Kit Recalled for Calibration Defect
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because a calibration defect causes all patient results to display as HIGH.
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: The recall is classified as High because the defect causes false positive results for a serious condition (lead poisoning), creating a risk of unnecessary medical intervention or delayed diagnosis, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Magellan Diagnostics, Inc. is recalling 1,465 units of the Magellan LeadCare II Blood Lead Test Kit, Catalog Number 70-6762. The affected product is an in vitro diagnostic test used for the quantitative measurement of lead in fresh whole blood. The recall covers Lot 1808M and its sub-lots (1808M-01 through 1808M-09), which have an expiration date of November 10, 2019.
The recall is due to a defect with the calibration button for Lot 1808M. This defect causes Level 1 and Level 2 Quality Control (QC) values to generate results of HIGH (>65 µg/dL). Consequently, results for patient testing with this specific lot will be displayed as HIGH, regardless of the actual lead level in the patient's blood.
The affected kits were distributed worldwide, including nationwide in the United States, as well as in Spain and South Africa. The product is intended for professional use only. Users should stop using the affected kits and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative me
- Manufacturer
- Magellan Diagnostics, Inc.
- Affected units
- 1,465
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 (10)
- Lot 1808M and sub-lots: 1808M-01
- 1808M-02
- 1808M-03
- 1808M-04
- 1808M-05
- 1808M-06
- 1808M-07
- 1808M-08
- 1808M-09. Exp. Date:November 10
- 2019
Distribution
Distributed nationwide across the United States.
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