The Recall Desk
SevereFDA (Devices)·Z-1954-2021·Announced 2021-07-07

LeadCare Ultra Blood Lead Test Kit Recalled for Control Test Inaccuracy

Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit due to control test failures causing potential underestimation of blood lead levels in patient samples. The recall involves 441 kits with worldwide distribution.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall. The rubric specifies that FDA Class I recalls must score no lower than 4. No deaths or serious injuries have been reported in the recall notice, which would be required for a Critical (5) rating. Therefore, the appropriate severity is 4 (Severe).

Plain-English summary

Magellan Diagnostics, Inc. is recalling the LeadCare Ultra Blood Lead Test Kit (Catalog Number 70-8098). The company received reports that control tests—either the Low-Control or High-Control—are generating low results, which may cause the underestimation of blood lead levels in patient samples.

The recall affects 441 kits containing 192 tests per kit, totaling 84,672 tests. The affected lot numbers and expiration dates are 2011MU (25 MAR 22), 2104MU (25 AUG 22), and 2108MU (31 MAR 22). The kits have been distributed worldwide, including the US, Puerto Rico, Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and the Philippines.

The recalled product

Product
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Manufacturer
Magellan Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
  • inaccurate-test-results

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

Distributed nationwide across the United States.

Related recalls

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