Drug screening tablets affected by temperature exposure during storage
McKesson is recalling Alere Toxicology drug screening tablets due to temperature excursions during facility storage that may have reduced product effectiveness. Affected units 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 recall for a medical device with a theoretical hazard—temperature exposure potentially affecting product effectiveness. No illnesses or injuries have been reported, which per the rubric limits this to a maximum score of 3.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Alere Toxicology drug screening tablets (Model Number 7875), medical devices used for drug screening. The product was distributed nationwide in the United States.
The recall was initiated because the manufacturing facility experienced temperature excursions between June and August 2021, prior to product shipment. These temperature excursions may have compromised the product's effectiveness.
The recall applies to all lots received between June 1, 2021 and September 30, 2021.
The recalled product
- Product
- Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- functional-failure
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: Unknown All lots received between 7/4/21-9/30/21
Distribution
Distributed nationwide across the United States.
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