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.
What this means for you
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
Same manufacturer · OraSure Technologies, Inc.
See all →- LowOraSure Methamphetamine Test Kit Recalled for Incorrect Reagent Lot Labeling
FDA (Devices) · 2021-03-17
- LowOraSure CVS Advanced Wart Remover Kit Recalled for Improper Sealing
FDA (Devices) · 2020-09-30
- LowOraSure Pointts Skin Tag Removal System Recalled for Unsealed Boxes
FDA (Devices) · 2020-09-30
- LowOraSure Personelle OTC Skin Tag Remover Recalled for Improperly Sealed Boxes
FDA (Devices) · 2020-09-30
- LowOraSure Benzodiazepine Micro-Plate Recalled for Incorrect Lot Number Labeling
FDA (Devices) · 2020-09-02
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02