FDA recall Z-1589-2022

Mckesson Medical-Surgical Inc. Corporate Office · Class II · device

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

Status
Ongoing
Initiation date
2022-05-25
Report date
2022-08-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, VA, United States

Primary source

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