Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233
Lot Codes / Batch Numbers
a. GTIN: Unknown All lots received between 7/4/21-9/30/21. b. GTIN:00815845020782, 10815845020789 All lots received between 7/4/21-9/30/21. c. GTIN:00858945006072, 10858945006079 All lots received between 7/4/21-9/30/21. d. GTIN: 00858945006133, 10858945006130 All lots received between 7/4/21-9/30/21. e. GTIN: 00817405020355, 00858945006829 All lots received between 7/4/21-9/30/21. f. GTIN: 00858945006508, 10816862020073, 00816862029079, 10815845020727 All lots received between 7/4/21-9/30/21. l. GTIN: 00815845020355, 10815845020352. m. GTIN: 00816862025415.
Products Sold
a. GTIN: Unknown All lots received between 7/4/21-9/30/21. b. GTIN:00815845020782; 10815845020789 All lots received between 7/4/21-9/30/21. c. GTIN:00858945006072; 10858945006079 All lots received between 7/4/21-9/30/21. d. GTIN: 00858945006133; 10858945006130 All lots received between 7/4/21-9/30/21. e. GTIN: 00817405020355; 00858945006829 All lots received between 7/4/21-9/30/21. f. GTIN: 00858945006508; 10858945006505 All lots received between 7/4/21-9/30/21. g. GTIN: 00817405020959 All lots received between 7/4/21-9/30/21. h. GTIN: 00816862020076; 10816862020073; 00816862029079; 00816862025071 All lots received between 7/4/21-9/30/21. i. GTIN: 00817405021192 All lots received between 7/4/21-9/30/21. j. GTIN: 00858998006104 All lots received between 7/4/21-9/30/21. k. GTIN: 00815845020720; 10815845020727 All lots received between 7/4/21-9/30/21. l. GTIN: 00815845020355; 10815845020352. m. GTIN: 00816862025415.
Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233 is recalling Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sam due to Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectivenes. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 sedgwick@sedgwick.com. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent possible patient harm. Please complete and return the enclosed response form as soon as possible even if you do not have any product on hand. Customers should contact Sedgwick directly by phone at 1-888-943-2401 to return the recalled products or if they have additional questions regarding this notification. Representatives are available Monday Friday, 8:00 am 5:00 pm PT
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026