TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.
FDA Recall Z-0491-2018 · Posted None
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Recalling FirmTosoh Bioscience Inc
Recall StatusTerminated
Product CodeKHO
Date Initiated2017-06-11
Date Terminated2019-12-31
Product Quantity565 total devices U.S.
Reason for Recall
This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.
Firm Action
Customers were sent a recall notification by email on July 11, 2017 informing them that their local Field Service Engineer would contact them to make arrangements to proactively replace the affected parts. Follow up notifications will be by Federal Express with verification of delivery.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - U.S. Nationwide - Latin America
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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