FDA Medical Device Recalls (openFDA)
OraSure Technologies, Inc.: Cannabinoids Intercept Micro Plate EIA 100 plate kit
- Recall number
- Z-0481-2009
- Recalling firm
- OraSure Technologies, Inc.
- Product
- Cannabinoids Intercept Micro Plate EIA 100 plate kit
- Status
- Terminated
- Initiated
- 2008-09-08
- Posted
- 2008-12-18
- Terminated
- 2008-12-18
- Reason
- Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820.
- Root cause
- Other
- Action
- On 9/8/08, the recalling firm telephoned the customer to inform them of the problem. As a follow up to the telephone call, the recalling firm issued a recall letter dated 9/11/08 to the customer.
- Quantity
- 1 kit
- Distribution
- The product was shipped to one customer in New York.
- Lot, serial or model codes
- Product number 11181C. Lot number 6609532 exp 12/2008
- 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