[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 — Incorrect lot number for Standard Oral Fluid Negat

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box

This Class III recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

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• OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device. — Class III

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.