Drugs of Abuse Test Kits Recalled Due to Temperature Exposure
McKesson Medical-Surgical is recalling multiple brands of drugs of abuse test kits because temperature excursions prior to delivery may have reduced product effectiveness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses, injuries, or deaths. The hazard is theoretical—product effectiveness may be impacted—and constitutes a voluntary precautionary recall. Per rubric guidelines, recalls with no reported incidents and theoretical hazards score at most 3, and this precautionary action without documented harm fits the Moderate category.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling multiple drugs of abuse test kits due to facility temperature excursions that occurred from June through August 2021. The recalled products include several models from Wondfo, Alere, and Instant Technologies manufacturers and are used to screen for various drugs of abuse in urine and saliva samples. Exposure to higher temperatures during this period may have impacted the effectiveness of these diagnostic tests.
The recall affects all lots that were received between June 1, 2021 and September 30, 2021 and were distributed nationwide. Laboratories, testing facilities, and other users who obtained these products should review their inventory from the affected timeframe to determine if replacement may be needed to ensure reliable test results.
The recalled product
- Product
- Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug Panel AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PPX, THC Urine S
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-exposure
- 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 (3)
- 10816862020073
- 00816862029079
- 10815845020352. m. GTIN: 00816862025415.
Distribution
Distributed nationwide across the United States.
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