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U.S. Department of Health and Human Services

Class 2 Device Recall Tosoh Automated Enzyme Immunoassay Analyzer AIA900

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 Class 2 Device Recall Tosoh Automated Enzyme Immunoassay Analyzer AIA900see related information
Date Initiated by FirmJune 11, 2017
Create DateJanuary 31, 2018
Recall Status1 Terminated 3 on December 31, 2019
Recall NumberZ-0491-2018
Recall Event ID 78776
Product Classification Fluorometer, for clinical use - Product Code KHO
ProductTosohAutomated 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.
Code Information All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.
FEI Number 3005529799
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact
614-317-1909
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCustomers 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.
Quantity in Commerce565 total devices U.S.
DistributionWorldwide Distribution - U.S. Nationwide - Latin America
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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