Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1589-2022 — 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 Sample 25 Tests Model

U.S. FDA — Device Enforcement · United States · 2022-05-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1589-2022
Date of alert: 2022-05-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Mckesson Medical-Surgical Inc. Corporate Office
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00815845020782

Reported risk: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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