The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1588-2022·Announced 2022-08-31

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.

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: 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
Category
Medical Device — Drug Screening / Diagnostics
Hazard
Affected units
1

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.

Part of a larger recall action

This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 55 products in this recall →

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