Tosoh recalls AIA-360 analyzers due to labeling changes affecting maintenance procedures. Failure to follow new requirements may cause corrosion, contamination, or system failure. Affected units have product code 019945/019945R.
The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD previously provided by Tosoh Bioscience. These changes are being made to align the Tosoh Quick Reference Guide and associated training materials to the Operators Manual and provide clarification to the requirement that the maintenance of the B/F probe is to be performed by Tosoh a field service representative, the requirement for use of 70% Ethanol during daily shutdown procedures and the requirement for use of CAP Class 1 reagent grade water for dilution of the concentrated wash and diluent solutions and reconstitution of lyophilized reagents. Failure to follow these requirements may negatively affect system performance, lead to corrosion of instrument components over time, or result in bacterial contamination, respectively.
Tosoh is recalling its AIA-360 Automated Immunoassay Analyzer (product codes 019945/019945R) because updated labeling changes affect maintenance procedures. If users don't follow the new requirements for probe maintenance, ethanol use, and water quality, the device could corrode, become contaminated, or malfunction.
The labeling changes require specific maintenance steps that must be followed by Tosoh field service representatives. If users skip these steps—like using the wrong water type or not properly cleaning probes—they risk corrosion, bacterial contamination, or device failure.
Users of the Tosoh AIA-360 Analyzer for in vitro diagnostics are affected. Laboratory staff and healthcare professionals who perform tests using this device are most at risk of system failure or contamination.
Check for the product code 019945 or 019945R on the device. The recall affects all units sold with these codes, as the labeling changes apply to all devices.
Check the device for new labeling changes that specify maintenance requirements for probes, ethanol use, and water quality.
Tosoh implemented new labeling changes to align training materials with the Operators Manual and clarify maintenance requirements for the device.
Failure to follow the updated requirements may cause corrosion of instrument components, bacterial contamination, or system failure.
The recall does not require returning the device; users must follow the updated labeling instructions to maintain proper function.
We’ve drafted a message you can send Tosoh to request your refund or repair — edit it as you like.
Subject: Recall Z-0559-2019 — Tosoh Tosoh Hello, I own a Tosoh that is covered by recall Z-0559-2019 from Tosoh. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
