The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1952-2021·Announced 2021-07-07

LeadCare II Blood Lead Test Kit Control Test Inaccuracy Recall

The LeadCare II Blood Lead Test Kit may generate artificially low control test results, causing blood lead levels to be underestimated in patient samples. Kits were distributed worldwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This FDA Class I medical device recall involves control test inaccuracy that can lead to underestimation of blood lead levels. No deaths or injuries are reported, but the Class I designation indicates reasonable probability of serious adverse health consequences.

Plain-English summary

Magellan Diagnostics, Inc. has recalled 387,281 LeadCare II Blood Lead Test Kits (Catalog Number 70-6762) due to control test inaccuracy. Control tests may generate artificially low results, which can cause blood lead levels in patient samples to be underestimated.

The affected kits were distributed worldwide, including throughout the United States and Puerto Rico, as well as Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and the Philippines. Multiple lot numbers from 2013M through 7114M with expiration dates between April 2022 and December 2022 are affected.

If you have used or have in possession a LeadCare II kit with a matching lot number, contact Magellan Diagnostics for recall instructions. Healthcare providers and laboratories should review results from affected kits for any potential impact on patient care decisions.

The recalled product

Product
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
Manufacturer
Magellan Diagnostics, Inc.
Category
Medical Device — Blood Lead Test Kit
Hazard

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 (20)

  • Lot Numbers/Expiration Date: 2013M - 22APR22
  • 2014M - 29APR22
  • 2015M - 12MAY22
  • 2016M - 19MAY22
  • 2017M - 10JUN22
  • 1st expansion 6/21/2021: 2101M - 28JUL22
  • 2103M - 18AUG22
  • 2105M - 11SEP22
  • 2106M - 21JAN22
  • 2107M - 30SEP22
  • 2nd expansion 8/30/2021
  • 2012M Sublots: -08
  • -09
  • -10
  • -11
  • -12
  • -13
  • -14 - 08APR22
  • 2018M - 06JUN22
  • 2102M - 30SEP21

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Magellan Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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