Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2877-2020 — Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT

U.S. FDA — Device Enforcement · United States · 2020-07-13 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2877-2020
Date of alert
2020-07-13
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
OraSure Technologies, Inc.
Product category
device
Product type
Devices
Reported risk: Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.