Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
Reported: September 2, 2020 Initiated: July 13, 2020 #Z-2877-2020
Product Description
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
Reason for Recall
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Details
- Recalling Firm
- OraSure Technologies, Inc.
- Units Affected
- 13 kits
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.
- Location
- Bethlehem, PA
Frequently Asked Questions
What product was recalled? ▼
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT. Recalled by OraSure Technologies, Inc.. Units affected: 13 kits.
Why was this product recalled? ▼
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 2, 2020. Severity: Low. Recall number: Z-2877-2020.
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