Z-0671-2019 Class II Terminated
FDA device recall Z-0671-2019 was initiated by Tosoh Bioscience Inc on November 30, 2018 and is designated Class II. Reason for recall: Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays The recall status is terminated (terminated January 14, 2021). Affected quantity: 29645 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2019
- Initiation Date
- November 30, 2018
- Termination Date
- January 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29645 units
Product Description
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.
Reason for Recall
Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays
Distribution Pattern
US Nationwide
Code Information
all lots