Fluorometer, For Clinical Use
Clinical Chemistry · 21 CFR 862.2560
Recent MDR events
4,519 adverse event reports on file
- AIA-360Jul 31, 2026MalfunctionTosoh Hi-tec, Inc.3004529019-2026-00105
- AIA-900Jul 31, 2026MalfunctionTosoh Hi-tec, Inc.3004529019-2026-00106
- AIA-2000Jul 30, 2026MalfunctionTosoh Bioscience, Inc. (ohio)3005529799-2026-00007
- AIA-900Jul 30, 2026MalfunctionTosoh Hi-tec, Inc.3004529019-2026-00104
- AIA-2000Jul 29, 2026MalfunctionTosoh Hi-tec, Inc.3004529019-2026-00102
- AIA-2000Jul 29, 2026MalfunctionTosoh Hi-tec, Inc.3004529019-2026-00103
- AIA-900Jul 28, 2026MalfunctionTosoh Hi-tec, Inc.3004529019-2026-00101
- AIA-900Jul 27, 2026MalfunctionTosoh Hi-tec, Inc.3004529019-2026-00100
- AIA-900Jul 21, 2026MalfunctionTosoh Hi-tec, Inc.3004529019-2026-00097
- AIA-2000Jul 21, 2026MalfunctionTosoh Hi-tec, Inc.3004529019-2026-00098
Event type breakdown
Recalls
32 recall events for this product code
- Tosoh Bioscience IncTerminatedFeb 11, 2020
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
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.
Z-1420-2020 · View FDA record ↗ - PerkinElmer Life and Analytical Sciences, Wallac, OYTerminatedJan 27, 2017
Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010
The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.
Z-1107-2017 · View FDA record ↗ - PerkinElmer Life and Analytical Sciences, Wallac, OYTerminatedJan 27, 2017
Spare Disk Remover Module; Product Number: 61001820
The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.
Z-1108-2017 · View FDA record ↗ - Tecan US, Inc.TerminatedJul 2, 2015
Infinite F500, in vitro diagnostic.
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Z-1967-2015 · View FDA record ↗ - Tecan US, Inc.TerminatedJul 2, 2015
Infinite M1000 PRO in vitro diagnostic.
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Z-1968-2015 · View FDA record ↗ - Tecan US, Inc.TerminatedJul 2, 2015
Infinite M1000 in vitro diagnostic.
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Z-1969-2015 · View FDA record ↗ - Tecan US, Inc.TerminatedJul 2, 2015
Infinite 200 PRO in vitro diagnostic.
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Z-1970-2015 · View FDA record ↗ - Tecan US, Inc.TerminatedJul 2, 2015
Infinite 200 in vitro diagnostic.
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Z-1971-2015 · View FDA record ↗ - Tecan US, Inc.TerminatedJan 15, 2015
Infinite 200
Incorrect lumi firmware version installed (E.027 instead of V2.00)
Z-0991-2015 · View FDA record ↗ - Tecan US, Inc.TerminatedJan 15, 2015
Infinite 200PRO
Incorrect lumi firmware version installed (E.027 instead of V2.00)
Z-0992-2015 · View FDA record ↗
Registered firms
69 firms currently registered for this product code
Ortho-clinical Diagnostics, Inc.
Carlsbad, CA, US
Quidel Cardiovascular Inc.
San Diego, CA, US
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Quidel Corp.
SAN DIEGO, CA, US
Tecan Trading Ag
Maennedorf Zurich, CH
Diamond Diagnostics Inc.
Budapest, HU
Ortho Clinical Diagnostics
Singapore South West, SG
Iul Sa
Barcelona, ES
Tosoh Hi-tec, Inc.
Yamaguchi, JP
Laboratorios Scantibodies, S.a. De C.v.
Tijuana Baja California, MX
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Carolina Liquid Chemistries
Brea, CA, US
Precision Biosensor Inc. 2nd Factory
Yuseong-gu Daejeon, KR
Via Systems Manufacturas
Tijuana Baja California, MX
Wallac Oy
TURKU Varsinais-Suomi, FI
Lacar Mdx Technologies
Liege, BE
Emsere, Inc.
Peachtree City, GA, US
Lre Medical Gmbh
NOERDLINGEN Bavaria, DE
Tosoh Corp.
Chuo-ku Tokyo, JP
Hologic, Inc.
SAN DIEGO, CA, US
W.h.p.m. Bioresearch & Technology Co., Ltd.
BEIJING, CN
Abionic Sa
Epalinges Vaud, CH
510(k) clearances
38 clearances for this product code
- Radiometer Medical ApsJan 20, 2012
K112161 · AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..
- Biosite IncorporatedJan 13, 1998
K973547 · TRIAGE STATMETER
- Tosoh Medics, Inc.Jun 27, 1997
K971103 · AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
- Johnson & Johnson Clinical Diagnostics, Inc.Oct 18, 1996
K962919 · VITROS IMMUNODIAGNOSTIC SYSTEM
- Biocircuits Corp.Nov 22, 1995
K952719 · BIOCIRCUITS IOS (IN-OFFICE SYSTEM)
- Isolab, Inc.Sep 5, 1995
K950415 · FLUOROSCAN NEONATAL
- Wallac OYMay 23, 1994
K935047 · AUTO DELFIA
- Bio-Chem Laboratory Systems, Inc.Nov 10, 1993
K930689 · AUTOBEAD THYROID UPTAKE