# FDA recall Z-1589-2022

> **Mckesson Medical-Surgical Inc. Corporate Office** · Class II · device recall initiated 2022-05-25.

## 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 Sample 25 Tests Model Number: DOA-1127-041-19.      c.  Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (OX, pH, SG) Urine Sample 25 Tests Model Number: I-DUA-157-013.      d.  Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 6-Drug Panel with Adulterants AMP, BZO, COC, mAMP/MET, OPI, THC, (OX, pH, SG) Urine Sample Tests Model Number: I-DUA-167-022.      e.  Alere Drugs of Abuse Test iCup Dx Pro 2 10-Drug Panel with Adulterants AMP, BAR, BUP, BZO, COC, mAMP/MET, OPI300, OXY, MTD, THC (CR, OX, SG) Urine Sample 25 Tests Model Number: I-DXP-2107-01.    f.  Alere Drugs of Abuse Test iScreen 5-Drug Panel AMP, COC, mAMP/MET, OPI, THC Urine Sam

## Reason for recall

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.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-1589-2022
- **Recalling firm:** Mckesson Medical-Surgical Inc. Corporate Office
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-25
- **Report date:** 2022-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1589-2022

## Citation

> AI Analytics. FDA recall Z-1589-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1589-2022. Source: US FDA. Licensed CC0.

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