Apparatus, High Pressure Liquid Chromatography
Clinical Chemistry · 21 CFR 862.2260
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Shimadzu Corp. Analytical & Measuring Instruments Div.Open, ClassifiedNov 26, 2024
Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.
Z-0553-2025 · View FDA record ↗ - Shimadzu Corp. Analytical & Measuring Instruments Div.Open, ClassifiedNov 26, 2024
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
There have been cases of failure of the main board due to condensation water occurring in the gap between thermal insulation material on the underside of the main base dropping onto the main board The symptoms and errors differ depending on the position where the water drops adhere. To date there have been examples of reports of inter-board communication errors, HOME POSITION error or SLIP error of XYZ drive units. The failure could result in delay of patient sample testing.
Z-0554-2025 · View FDA record ↗
Registered firms
10 firms currently registered for this product code
Shimadzu Corporation Analytical&measuring Instruments Div.
KYOTO, JP
Ab Sciex Lp
Concord Ontario, CA
Spark Holland Bv.
EMMEN Drenthe, NL
Ab Sciex Pte. Ltd.
Woodlands Central Industrial Estate Central Singapore, SG
Thermo Finnigan Llc
San Jose, CA, US
Agilent Technologies
Waldbronn Baden-Wurttemberg, DE
Agilent Technologies Singapore (international) Pte Ltd.
Singapore North East, SG
Shimadzu U.s.a. Manufacturing, Inc.
Canby, OR, US
Agilent Technologies, Inc
Santa Clara, CA, US
Waters Corporation
MILFORD, MA, US
510(k) clearances
25 clearances for this product code
- Waters CorporationNov 29, 1996
K964588 · WATERS 515 HPLC PUMP (515)
- The Perkin-Elmer Corp.Apr 26, 1994
K935666 · PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP
- Millipore Corp.Dec 11, 1992
K924347 · WATERS(TM) 996 PDA
- Millipore Corp.Dec 10, 1991
K914841 · CHROMATOGRAPHY CLINICAL USE 75JQR
- Rohm and Haas Co.Apr 8, 1991
K911299 · EQUIPMENT/MATERIAL DECONTAMINATING KIT
- Millipore Corp.Jul 29, 1986
K862506 · THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR
- Syva Co.Jun 28, 1985
K844947 · EMIT ANCILLARY REAGENTS
- Syva Co.Feb 15, 1985
K844949 · SYVA SAMPLE SEAL