CLASS II Device recall · Reported 11 Mar 2020 · FDA Enforcement Report

AIA-360 Automated Immunoassay Analyzer, Product recalled

Tosoh Bioscience is recalling AIA-360 Automated Immunoassay Analyzer, Product, distributed in Arizona, Nebraska, New Jersey, New York, Washington. The recall was initiated on 10 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes28469102 28629205 28469202 28629305 28469302 28629405 28469402 28629505 28469502 28629605 28469602 28629705 28469702 28709907 28469802 28719007 28469902 28719107 28479002 28719207 28519303 28719307 28519403 28719407 28519503 28719507 28519603 28719607 28519703 28719707 28519803 28719807 28519903 28719907 28529003 28729007 28529103 28729108 28529203 28729208 28529903 28729308 28539003 28729408 28539103 28729508 28539203 28729608 28539303 28759908 28539403 28769008 28539503 28769108 28539603 28769208 28539703 28769308 28539803 28769408

Quantity recalled12

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1420-2020
FDA event ID: 84787
Recalling firm: Tosoh Bioscience, Grove City, OH
Classification: Class II
Status: Terminated
Recall initiated: 10 Jan 2020
FDA classified: 2 Mar 2020
Reported: 11 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

10 Jan 2020	Recall initiated by company
2 Mar 2020	Classified by FDA	+52 days
11 Mar 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

AIA-360 Automated Immunoassay Analyzer, Product Code 019945

Where it was distributed

Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay

Arizona Nebraska New Jersey New York Washington

Questions about this recall

Is AIA-360 Automated Immunoassay Analyzer, Product recalled?

Yes. Tosoh Bioscience recalled AIA-360 Automated Immunoassay Analyzer, Product on 10 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1420-2020.

Why was it recalled?

Which lots are affected?

28469102 28629205 28469202 28629305 28469302 28629405 28469402 28629505 28469502 28629605 28469602 28629705 28469702 28709907 28469802 28719007 28469902 28719107 28479002 28719207 28519303 28719307 28519403 28719407 28519503 28719507 28519603 28719607 28519703 28719707 28519803 28719807 28519903 28719907 28529003 28729007 28529103 28729108 28529203 28729208 28529903 28729308 28539003 28729408 28539103 28729508 28539203 28729608 28539303 28759908 28539403 28769008 28539503 28769108 28539603 28769208 28539703 28769308 28539803 28769408

Where was it sold?

Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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