FDA Device recall Z-0310-2016
EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple dr…
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple dr… by Ameditech, citing ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0310-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-20 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ameditech |
| Distribution | US |
Product
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.
Reason
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Identifiers
| code_info | 134268 134898 140206 140218 140453 140551 141053 141129 143471 143553 144468 144557 150317 150531 150606…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0310-2016%22
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