FDA Medical Device Recalls (openFDA)
OraSure Technologies, Inc.: 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.
- Recall number
- Z-0722-2017
- Recalling firm
- OraSure Technologies, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2016-11-10
- Posted
- 2016-12-08
- Terminated
- 2017-04-17
- Reason
- Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
- Root cause
- Mixed-up of materials/components
- Action
- Due to the small number of customers that were affected by the recall, OraSure notified customers on November 10, 2016, via telephone with a follow-up email. Customers were asked to quarantine the units on hand and they will schedule a pickup by Fed EX to retrieve the affected units. For further questions, please call (610) 882-1820, ext. 1657
- Quantity
- 4 kits
- Distribution
- Distributed to KS, and VA
- Lot, serial or model codes
- Lot # 6654085
- 510(k) numbers
- ["K001976"]
- PMA numbers
- not on file
- Product code
- DIS
- 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