Ameditech Inc: Medical Device Recall in 2020 - (Recall #: Z-3034-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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"

Product Classification:

Class II

Date Initiated: August 18, 2020

Date Posted: October 7, 2020

Recall Number: Z-3034-2020

Event ID: 86335

Reason for Recall:

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.

Status: Terminated

Product Quantity: 108,000 units

Code Information:

ALL Lots Within Expiry

Distribution Pattern:

US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain

Voluntary or Mandated:

Voluntary: Firm initiated