Z-0491-2018Class II

TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930

Name: Z-0491-2018 TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930
Creator: Tosoh Bioscience Inc
Published: 2017-06-11
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2017-06-11 / Terminated / root cause: manufacturing process

FDA source

Tosoh Bioscience Inc began a recall of TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated... on 2017-06-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0491-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-11
Posted: 2018-01-31
Terminated: 2019-12-31
Recalling firm: Tosoh Bioscience Inc
Product: 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.
Product code: KHO Fluorometer, For Clinical Use
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 565 total devices U.S.
Distribution: Worldwide Distribution - U.S. Nationwide - Latin America
Product codes and lots: All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0491-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0491-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-30
Z-0492-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-30

Product code KHO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)