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Recall Observatory FDA recall evidence

Device product

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.

Z-0672-2019

November 30, 2018

Class II

Product summary

Firm
Tosoh Bioscience Inc
Event
Event 81597
Status
Terminated
Classification
Class II
Quantity
19366 units
Official record key
device-enforcement:Z-0672-2019

Official wording

Reason: Unavailable

Code information: all lots

Distribution pattern: US Nationwide