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

Recall Z-2967-2020 — Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay

U.S. FDA — Device Enforcement · United States · 2020-08-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2967-2020
Date of alert
2020-08-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Tosoh Bioscience Inc
Product category
device
Product type
Devices
Reported risk: Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
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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