Class III — OraSure Technologies, Inc.
| Recalling firm | ORASURE TECHNOLOGIES, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing. |
| 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. |
| Quantity | 4 kits |
| Distribution | Distributed to KS, and VA |
| Initiated | 2016-11-10 |
| Classified | 2016-12-08 |
| Terminated | 2017-04-17 |
| Recall number | Z-0722-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — OraSure Technologies, Inc. (Z-0722-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75681/
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