Tosoh Bioscience Inc Recall: Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test
Tosoh Bioscience Inc Recall: Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Tosoh Bioscience Inc; Product: Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number:
| Recalling firm | Tosoh Bioscience Inc |
|---|---|
| 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 |
| 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%. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador. |
| Recall initiated | 20200807 |
| Recall number | Z-2968-2020 |
| Category | device |
| State | OH |
| Country | United States |
$29/mo
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