Barbiturates Intercept Micro-Plate EIA — Class III medical device recall Z-0722-2017
Terminated recall by OraSure Technologies, Inc., reported 2016-12-14, distributed in KS, VA. Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect s
| Recall number | Z-0722-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OraSure Technologies, Inc., Bethlehem, PA, United States |
| Recall initiated | 2016-11-10 |
| Classified | 2016-12-08 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2017-04-17 |
| Distributed | KS, VA |
| Quantity | 4 kits |
| Lot numbers | 6654085 |
Product
Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
Reason for recall
Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0722-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.