RecallRadar

FDA Device recall Z-0599-2019

AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three…

On 2018-12-19 the FDA classified a Class II recall of AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three… by Tosoh Bioscience, citing tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0599-2019
ClassificationClass II
Statusterminated
Initiated2018-09-28
Published2018-12-19
Last updated2026-09-13 11:54 UTC
CompanyTosoh Bioscience
DistributionUS

Product

AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.

Reason

Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.

Identifiers

code_infoAffects all active analyzers. 022100, 022100R, 022101, 022101R

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Other recalls by Tosoh Bioscience

All Tosoh Bioscience recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0599-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.