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Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine...

FDA Device Recall #Z-1589-2022 — Class II — May 25, 2022

Recall Summary

Recall Number Z-1589-2022
Classification Class II — Moderate risk
Date Initiated May 25, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Mckesson Medical-Surgical Inc. Corporate Office
Location Richmond, VA
Product Type Devices
Quantity a. unk b. 6 c. 1 d. 1 e. 67 f. 1 g. 10 h. 51 i. 27 j. 105 k. 4 l. 2 m. 3

Product Description

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 Sample 25 Tests Model Number: IS5M. g. Instant Technologies, Inc. Drugs of Abuse Test T-Cube 7-Drug Panel AMP50, COC20, mAMP/MET50, OPI40, OXY20, PCP10, THC40 Saliva Sample 25 Tests Model Number: TCUBE-7PCPB. h. Wondfo Drugs of Abuse Test with Adulterants Tcup 14-Drug Panel AMP1000, BAR300, BZO300, BUP10, COC300, mAMP/MET1000, MDMA500, MTD300, MOP(OPI300), OXY100, PCP25, PPX300, TCA1000, THC50 (CR, pH, SG) Urine Sample 25 Tests Model Number: TDOA-1145A3. i. Instant Technologies, Inc. Drugs of Abuse Test UScreen 12-Drug Panel with Adulterants AMP, BAR, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PCP, TCA, THC, (CR, pH, SG) Urine Sample 25 Tests Model Number: USSCUPA-12CLIA. j. Instant Technologies, Inc. Drugs of Abuse Test UScreen 12-Drug Panel with Adulterants AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PCP, THC (CR, pH, SG) Urine Sample 25 Tests Model Number: USSCupA-12BUP300. k. Alere Drugs of Abuse Test E-Z Split Key Cup 6-Drug Panel AMP, BZO, COC, mAMP/MET, OPI, THC Urine Sample 25 Tests Model Number: DOA-2167-019. l. Alere Drugs of Abuse Test E-Z Split Key Cup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (CR, GL, NI, OX, pH, SG) Urine Sample 25 Tests Model Number: DUD-157-012-019. m. WONDFO USA CO., LTD. Wondfo Drug Test Dip Card Drugs of Abuse Test Tdip Single Drug Buprenorphine (BUP) Urine Sample 25 Tests Model Number: WDBU-114.

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 Pattern

US Nationwide

Lot / Code Information

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.

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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