Agency classClass IIIOur severity:Low FDA (Devices)·Z-2877-2020·Announced 2020-09-02

OraSure Benzodiazepine Micro-Plate Recalled for Incorrect Lot Number Labeling

OraSure Technologies is recalling 13 kits of Interept Benzodiazepine Micro-Plates due to incorrect lot numbers on specification sheets and unit boxes.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error.

Plain-English summary

OraSure Technologies, Inc. is recalling 13 kits of the Interept Benzodiazepine Micro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate, Product Number 1110IT. The recall is due to an incorrect lot number for the Standard Oral Fluid Negative Calibrator listed on the specification sheet included in the kit and/or on the unit box.

The affected product is an In Vitro Diagnostic (IVD) immunoassay for benzodiazepines. The specific lot number is 6673116, with an expiration date of 03/31/2020. The product was distributed worldwide, including nationwide in the United States (specifically DC, FL, PA, MD, NM, NY, NV) and in France.

Consumers and healthcare facilities should stop using the affected kits and contact OraSure Technologies for instructions on return or replacement. This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product: Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
Manufacturer: OraSure Technologies, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
Affected units: 13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot Number: 6673116 Exp. Date:03/31/2020

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 recalled by OraSure Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · OraSure Technologies, Inc.

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Same hazard · mis labeling