FDA Medical Device Recalls (openFDA)
Ameditech Inc: Fastect II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description): MF25/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect II Drug Screen Dipstick Test, 4 Drug Detection: THC50+COC300+OPI300+BZO300", MF20/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: MTD300", MF21/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: TCA1000, MF23/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF23/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF18/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BZO300, MF18/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BZO300", QF12/ "Fastect II Drug Screen Dipstick Test 4 Drug Detection: THC50+COC300+OPI300+MET500", MF10/ "Fastect II Drug Screen Dipstick Test THC50", MF25/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF16 /"Fastect II Drug Screen Dipstick Test Single Drug Detection: MET500", MF23 /"Fastect II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF14/ "Fastect II Drug Screen Dipstick Test AMP1000", MF11/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: COC300", MF23 / Fastect II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF25/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF25/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF23/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: OXY100"
- Recall number
- Z-3034-2020
- Recalling firm
- Ameditech Inc
- Product
- Fastect II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description): MF25/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect II Drug Screen Dipstick Test, 4 Drug Detection: THC50+COC300+OPI300+BZO300", MF20/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: MTD300", MF21/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: TCA1000, MF23/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF23/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF18/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BZO300, MF18/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BZO300", QF12/ "Fastect II Drug Screen Dipstick Test 4 Drug Detection: THC50+COC300+OPI300+MET500", MF10/ "Fastect II Drug Screen Dipstick Test THC50", MF25/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF16 /"Fastect II Drug Screen Dipstick Test Single Drug Detection: MET500", MF23 /"Fastect II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF14/ "Fastect II Drug Screen Dipstick Test AMP1000", MF11/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: COC300", MF23 / Fastect II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF25/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF25/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF23/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: OXY100"
- Status
- Terminated
- Initiated
- 2020-08-18
- Posted
- not on file
- Terminated
- 2024-09-30
- Reason
- Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
- Root cause
- Process control
- Action
- A Field Corrective Action Notice letter was sent to affected consignees. The Customer notifications commenced on 19-Aug-2020. The consignees are requested to return all non-expired product in their possession to the recalling firm. Method of Notification, 1st contact: Written field corrective action notification letters will be sent via certified mail with delivery tracking to each consignee along with a pre-paid return label to return any product remaining in stock. 2nd & 3rd contact: Telephone, follow up email, or written mail communication will be used as necessary.
- Quantity
- 108,000 units
- Distribution
- US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
- Lot, serial or model codes
- ALL Lots Within Expiry
- 510(k) numbers
- ["K022355","K030113"]
- PMA numbers
- not on file
- Product code
- DIO
- Firm FEI
- 3003789989
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28