Cocaine Metabolite MICRO-PLATE EIA — Class III medical device recall Z-1419-2018
Terminated recall by OraSure Technologies, Inc., reported 2018-04-25, distributed in KS. The controls and calibrators contained within the cocaine test kit may cause false positive results with the n
| Recall number | Z-1419-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OraSure Technologies, Inc., Bethlehem, PA, United States |
| Recall initiated | 2017-12-20 |
| Classified | 2018-04-18 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2020-04-02 |
| Distributed | KS |
| Quantity | 10 |
| Lot numbers | 0006661251 |
| Model numbers | 1122SC |
| Expiration dates | 2018-02-28 |
Product
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
Reason for recall
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
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-1419-2018. 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.