LeadCare II Blood Lead Test Kit Recalled Due to Temperature Storage Issues
81 kits of LeadCare II blood lead test devices were recalled because temperature exposure during storage may have impacted product effectiveness. The affected lots were received between June and September 2021.
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: This is an FDA Class II medical device recall with theoretical risk of harm (reduced test effectiveness) but no reported illnesses or injuries. The hazard meets the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling 81 kits of the LeadCare II Blood Lead Test Kit, a rapid blood test used to detect lead levels in whole blood samples.
The recall was initiated due to facility temperature excursions that occurred from June through August 2021 prior to product delivery. Exposure to higher temperatures during storage may have impacted the product's effectiveness and accuracy as a diagnostic test.
All kits with lot numbers distributed between June 1 and September 30, 2021 are affected by this recall. These kits were distributed nationwide.
Consumers and healthcare providers who received affected kits should discontinue use and contact Mckesson Medical-Surgical Inc. for replacement instructions or further information regarding this recall.
The recalled product
- Product
- MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests Model Number: 70-6762
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-damage
- reduced-effectiveness
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)
- GTIN: 00850355006000
Distribution
Distributed nationwide across the United States.
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