Tosoh Bioscience Inc: Medical Device Recall in 2020 - (Recall #: Z-2968-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay

Product Classification:

Class II

Date Initiated: August 7, 2020

Date Posted: September 23, 2020

Recall Number: Z-2968-2020

Event ID: 86218

Reason for Recall:

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%.

Status: Terminated

Product Quantity: 39 boxes

Code Information:

Lot Numbers: J803507, JX03508, JZ03509, A203510, A403511

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.

Voluntary or Mandated:

Voluntary: Firm initiated