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Colorimeter, Photometer, Spectrophotometer For Clinical Use

FDA product code JJQ · Class 1 · Clinical Chemistry

221
Registered devices
355
Adverse events
17
Recalls
258
510(k) clearances

Devices with this code

CYT5FAW-SI — AGILENT TECHNOLOGIES, INC.SH1MF-SI — AGILENT TECHNOLOGIES, INC.SH1M2G-SI — AGILENT TECHNOLOGIES, INC.FastPack® IP System — QUALIGEN INC.H1MG-SI — AGILENT TECHNOLOGIES, INC.CYT5FW-SI — AGILENT TECHNOLOGIES, INC.Epoch-SI — AGILENT TECHNOLOGIES, INC.SUNRISE-RC/TW EVOLYZER — Tecan Austria GmbHIMMULITE 2000/XPi Probe Cleaning Kit — Siemens Healthcare Diagnostics Products GmbHC10MPW-SI — AGILENT TECHNOLOGIES, INC.SUNRISE-RC/ST EVOLYZER — Tecan Austria GmbH800TSUV-SI — AGILENT TECHNOLOGIES, INC.LP580-SI — AGILENT TECHNOLOGIES, INC.StatFax — AWARENESS TECHNOLOGY, INCORPORATEDCYT5PW-SI — AGILENT TECHNOLOGIES, INC.SLXFA-SI — AGILENT TECHNOLOGIES, INC.LP640-SI — AGILENT TECHNOLOGIES, INC.800TSNB-SI — AGILENT TECHNOLOGIES, INC.StatFax — AWARENESS TECHNOLOGY, INCORPORATEDINFINITE 200 PRO — Tecan Austria GmbHSLXF-SI — AGILENT TECHNOLOGIES, INC.CYT5MPW-SI — AGILENT TECHNOLOGIES, INC.CYT5MFAV-SI — AGILENT TECHNOLOGIES, INC.ChemWell2 — AWARENESS TECHNOLOGY, INCORPORATED

Recent recalls

DateFirmReason
2025-09-23Becton Dickinson & Co.Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product se
2022-10-03Beckman Coulter, Inc.Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2011-01-12QIAGEN Gaithersburg, Inc.The software component of a diagnostic medical device may be defective and could cause incorrect patient values.
2009-03-12BioTek Instruments, Inc.Software design allowed false negatives to be read when wells are dark.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.