Z-0477-2009

Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit

Name: Z-0477-2009 Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit
Creator: OraSure Technologies, Inc.
Published: 2008-09-08
License: https://open.fda.gov/license/

OraSure Technologies, Inc. / initiated 2008-09-08 / Terminated / root cause: manufacturing process

FDA source

OraSure Technologies, Inc. began a recall of Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit on 2008-09-08. The reason FDA records is "Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0477-2009
Status: Terminated
Initiated: 2008-09-08
Posted: 2008-12-23
Terminated: 2009-05-05
Recalling firm: OraSure Technologies, Inc.
Product: Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit.
Product code: LDJ Enzyme Immunoassay, Cannabinoids
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Product number 61456. Lot numbers 6604829, 6604836, 6606036, 6606585, and 6606591

Product code LDJ

K002375Class IIStc Cannabinoids Intercept Micro-Plate Eia, Model 1118IOraSure Technologies, Inc. / cleared 2001-01-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)