medical Class II Updated 2020-09-23

Tosoh Bioscience Inc recalls Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagn

Recalled Product

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

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: J833531, JX33532, JZ33533, A233534, A433535
View official government recall

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