Ameditech Inc: Medical Device Recall in 2015 - (Recall #: Z-0310-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

Product Classification:

Class II

Date Initiated: October 20, 2015

Date Posted: November 25, 2015

Recall Number: Z-0310-2016

Event ID: 72471

Reason for Recall:

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Status: Terminated

Product Quantity: 70364 units

Code Information:

134268 134898 140206 140218 140453 140551 141053 141129 143471 143553 144468 144557 150317 150531 150606 150638 150834 151154 152021 152104 134067 134504 140495 141010 141128 141197 143716 143784 143866 144003 144042 144199 144270 144332 144443 144502 144555 150237 150347 150440 150901 150989 151239 151925 151984 152003 152103

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Internationally to Australia.

Voluntary or Mandated:

Voluntary: Firm initiated