FDA Device recall Z-1419-2018
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
- FDA Device
- Class III
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class III recall of Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000 by Orasure Technologies, citing the controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1419-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-12-20 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orasure Technologies |
| Distribution | KS |
Product
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
Reason
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Identifiers
| code_info | Lot Number: 0006661251, Expiration date: 02/28/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1419-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.