AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
Reported: January 2, 2019 Initiated: November 30, 2018 #Z-0672-2019
Product Description
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
Details
- Recalling Firm
- Tosoh Bioscience Inc
- Units Affected
- 19366 units
- Distribution
- US Nationwide
- Location
- Grove City, OH
Frequently Asked Questions
What product was recalled? ▼
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.. Recalled by Tosoh Bioscience Inc. Units affected: 19366 units.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 2, 2019. Severity: Moderate. Recall number: Z-0672-2019.
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