Reported Jul 1, 2020 · Terminated
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Tosoh Bioscience Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tosoh Bioscience Inc · 3600 Gantz Rd · Grove City, OH · 43123-1895
Is this the product you have?
AIA-900 AnalyzerPart no. 022930UDI 04560189283992
- Lot codes and dates
- From customer letter
Serial numbers 100308101010100810142204102124111025390210263902
- and higher serial numbers Complete list(Distributed in US)(Distributed Internationally)
330 of 330 codes
1003081010050912100714021010100810142204101623051020291110212411102223121025390210263902102730021030310410303904103131051031360510333005103339061034300610343307103535071035360710353707R10353807103539071036350710363608103731081037340810373508103931081039320810393308103939081041300910413509104234091042390910433009104431101044321010443310104437101045331010453410104538101045391010463010104631101047311110473211104733111047341110483411104835111049311110493411104937111049391110503011
69 of 69 codes
100810021027360310303804R10343407R10413909R10423809R10483211105646011056470110564901105940021059480210614402R10634303R106346031066430410674505106746051069450610734208R1073430810744309107444091074460910855903108650031100660111026101110262011102630111026702110268021102690211046205R11076209R11086710111061121110621211106312111064121110651211187906111970061119710611197206111973061124750911247809112676101129781211368506113686061136870611368806113689061137800611398708113988081139890811408008
- From customer letter
- Amount recalled
- 529
Where it was sold
- Nationwide
Why it was recalled
The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.
This product could cause temporary or reversible health problems — stop using it.
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