OraSure Technologies, Inc. Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Plate EIA kit. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Plate EIA kit.
Brand
OraSure Technologies, Inc.
Lot Codes / Batch Numbers
Product Number 61452. Lot numbers 6604827, 6604834, 6606583, 5506589, and 6606034
Products Sold
Product Number 61452. Lot numbers 6604827, 6604834, 6606583, 5506589, and 6606034
OraSure Technologies, Inc. is recalling Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Plate EIA ki due to Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CT, DE, FL, GA, ID, KS, KY, MD, MA, MI, NV, NH, NY, NC, PA, VA, WY
Page updated: Jan 10, 2026