The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3035-2017·Announced 2017-08-23

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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.
Category
Medical Device — In Vitro Diagnostics
Hazard
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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