FDA Device recall Z-0270-2019
Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple dru…
- FDA Device
- Class III
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class III recall of Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple dru… by Ameditech, citing product was released to market without the adulteration strip included in the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0270-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-09-30 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ameditech |
| Distribution | CA |
Product
Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the presence or absence of drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process-is provided in the package labeling.
Reason
Product was released to market without the adulteration strip included in the product.
Identifiers
| code_info | Part Number: DS84S625, Lot Number: 174886 (US distribution only) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0270-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.