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 | The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control. |
| Product | Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000 |
| Quantity | 10 |
| Distribution | Distributed to 2 consignees in KS. |
| Initiated | 2017-12-20 |
| Classified | 2018-04-18 |
| Terminated | 2020-04-02 |
| Recall number | Z-1419-2018 |
| 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-1419-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79534/
Alerts for ORASURE TECHNOLOGIES, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.