FDA Medical Device Recalls (openFDA)
OraSure Technologies, Inc.: Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Plate EIA kit.
- Recall number
- Z-0478-2009
- Recalling firm
- OraSure Technologies, Inc.
- Product
- Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Plate EIA kit.
- Status
- Terminated
- Initiated
- 2008-09-08
- Posted
- 2008-12-23
- Terminated
- 2009-05-05
- Reason
- Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued a letter entitled "URGENT PRODUCT RECALL NOTICE" dated 9/8/08 to their customers to inform them of the problem and the need to return the product.
- Quantity
- 2198 units
- Distribution
- Worldwide Distribution --- USA including states of AZ, CA, CT, DE, FL, GA, ID, KS, KY, MA, MD, MI, NC, NH, NV, NY, PA, VA, and WY, and countries of United Kingdom, Italy, Germany, and Canada.
- Lot, serial or model codes
- Product Number 61452. Lot numbers 6604827, 6604834, 6606583, 5506589, and 6606034
- 510(k) numbers
- ["K002375"]
- PMA numbers
- not on file
- Product code
- LDJ
- 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