medical Class II Updated 2020-09-23

Tosoh Bioscience Inc recalls Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test

Recalled Product

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

Hazard / Issue

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%.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: J803507, JX03508, JZ03509, A203510, A403511
View official government recall

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