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.
Reported: January 2, 2019 Initiated: November 30, 2018 #Z-0671-2019
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
Details
- Recalling Firm
- Tosoh Bioscience Inc
- Units Affected
- 29645 units
- Distribution
- US Nationwide
- Location
- Grove City, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Tosoh Bioscience Inc. Units affected: 29645 units.
Why was this product recalled? ▼
Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 2, 2019. Severity: Moderate. Recall number: Z-0671-2019.
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