OraSure Benzodiazepine Micro-Plate Recall Due to Incorrect Lot Number Labeling
OraSure Technologies is recalling 39 kits of the Interept Benzodiazepine Micro-Plate EIA due to incorrect lot numbers on the specification sheet and unit box.
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 indicates the product is not likely to cause adverse health consequences. The issue is a documentation/labeling error regarding the lot number, which fits the criteria for a Low severity score.
Plain-English summary
OraSure Technologies, Inc. is recalling 39 kits of the Interept Benzodiazepine Micro-Plate EIA (Product Number: 1110IB). 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 IVD immunoassay for benzodiazepines. The specific lot number is 6673115 with an expiration date of 03/31/2020. The UDI is 608337000238. The product was distributed worldwide, including in the United States (DC, FL, PA, MD, NM, NY, NV) and France.
Consumers and healthcare facilities should check their inventory for this specific product number and lot number. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to their instructions.
The recalled product
- Product
- Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
- Manufacturer
- OraSure Technologies, Inc.
- Hazard
- Affected units
- 39
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: 6673115 Exp. Date:03/31/2020 UDI: 608337000238
Distribution
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 →Related recalls
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