FDA Medical Device Recalls (openFDA)
OraSure Technologies, Inc.: Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
- Recall number
- Z-1419-2018
- Recalling firm
- OraSure Technologies, Inc.
- Product
- Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
- Status
- Terminated
- Initiated
- 2017-12-20
- Posted
- not on file
- Terminated
- 2020-04-02
- Reason
- The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
- Root cause
- Under Investigation by firm
- Action
- The email to the firm's consignees states the controls will be replaced.
- Quantity
- 10
- Distribution
- Distributed to 2 consignees in KS.
- Lot, serial or model codes
- Lot Number: 0006661251, Expiration date: 02/28/2018
- 510(k) numbers
- ["K982061"]
- PMA numbers
- not on file
- Product code
- DIO
- Firm FEI
- 2528909
- Firm city
- Bethlehem
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28