Magellan LeadCare II Blood Lead Test Kit Recall for Out-of-Range Controls
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because the lead controls were out of range. The recall affects 12,931 kits distributed worldwide.
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 FDA Class II, which corresponds to a High severity score under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Magellan Diagnostics, Inc. is recalling the LeadCare II Blood Lead Test Kit, which includes LeadCare II Lead Controls. The recall is a field correction action because the lead controls packaged in specific lots were found to be out of range. The kit is an in vitro diagnostic (IVD) test used for the detection of lead in blood.
The recall affects 12,931 kits. The specific lots involved are 1507N, 1508N, 1510N, 1511M, 1511N, and 1512M, with expiration dates ranging from January 27, 2017, to June 2, 2017. The products were distributed nationwide in the United States and in several international countries, including Colombia, Canada, Thailand, India, UAE, Australia, Germany, South Africa, Spain, New Zealand, and Korea.
Healthcare providers and consumers should stop using the affected LeadCare II Lead Controls. The recall is classified as FDA Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a
- Manufacturer
- Magellan Diagnostics, Inc.
- Affected units
- 12,931
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 (3)
- Lot # :1507N Exp Date: 1/27/17
- Lot # :1508N Exp Date: 2/27/17
- Lot # :1510N Exp Date: 4/19/17
Distribution
Distributed nationwide across the United States.
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