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Hamilton Co.

United Statesfrom the FDA registration address FDA FEI 2915796

Devices
16
Registrations
FDA
FDA recalls
131 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

Catalogue16

Newest first, rows 1-16 of 16

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  • Discrete Photometric Chemistry Analyzer Ref K943493

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Microlab P Ref K832204

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Pb 600 Repeating Dispenser Ref K832202

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Multi-Probe Head Plus Ref K892369

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Precision Liquid Dispenser Ref K832205

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Chrom-Prep Ref K832201

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Digital Diluter/Dispensers Ref K822688

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Microlab M-Microprocessor Diluter/Disp Ref K801913

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • HC40/HC75 Prepacked Colums Ref K832198

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • HC40/HC75 Cation Exchange Resin Ref K832199

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Lumicon Ref K873893

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Microlab At Ref K871945

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Prp-1 Reversed Phase Resin Ref K832197

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Microlab 4000, Microlab 4200 Ref K961896

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Multi-Titer Dispenser Ref K832203

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Prp-1 Reversed Phase Columns For Hplc Ref K832200

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-16 of 16

Company details

FDA FEI number
2915796
Address
4970 ENERGY WAY, Reno, NV, 89502

FDA recalls13

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 1
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

12 initiated before 2017

Showing the 10 most recent of 13 recalls.

  • 2021

    • 15 Jan 2021 Z-1156-2021 Class II Ongoing There is a risk that the device can start a fire if flammable liquids contact and enter the device. Distribution: US - AL, AR, AZ, CA, CO, CT, DC. DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA. MD, ME. MI, MN, MO, MS, MT, NC, NH, NJ,…
      Full distribution text US - AL, AR, AZ, CA, CO, CT, DC. DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA. MD, ME. MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI AND WY OUS - AUSTRALIA, AUSTRIA, BRAZIL , CANADA , CHILE, CHINA, , COLOMBIA , FINLAND , GERMANY , ITALY , JAPAN , JPN , KOREA, SOUTH, PARAGUAY , PERU , PHL , ROMANIA , ROU , SINGAPORE, SWITZERLAND , SWITZERLAND , THAILAND, TWN , UNITED KINGDOM, AND URUGUAY

  • 2011

    • 26 Sep 2011 Z-0103-2012 Unclassified (pre-2012) Terminated Certain lots of syringes have caused an increase in error message "DIS541", which indicates "improper dispensation". Distribution: Worldwide distribution: USA(nationwide) including states of: NJ, NV, TX and WA; and countries of: Brazil, P.R. China,…
      Full distribution text Worldwide distribution: USA(nationwide) including states of: NJ, NV, TX and WA; and countries of: Brazil, P.R. China, France and Germany.
      Submission number: K943493

  • 2009

    • 9 Apr 2009 Z-1999-2009 Unclassified (pre-2012) Terminated Product Defect-- some tips from the mold cavity 28 are too short and do not always aspirate or dispense liquid correctly. Distribution: Worldwide Distribution -- US (states of DE, NJ, PA, MA and CA), New Zealand and Japan.

  • 2008

    • 1 Dec 2008 Z-1203-2009 Unclassified (pre-2012) Terminated Some tips may be occluded and are unable to aspirate or dispense liquid. Distribution: Nationwide Distribution -- MA, CA, MN, CT, and NC.
    • 7 May 2008 Z-2232-2008 Unclassified (pre-2012) Terminated Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity Distribution: Product distributed throughout the US and to Puerto Rico, New Zealand, Australia, Japan and Canada.
    • 7 May 2008 Z-2233-2008 Unclassified (pre-2012) Terminated Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity Distribution: Product distributed throughout the US and to Puerto Rico, New Zealand, Australia, Japan and Canada.

  • 2007

    • 25 Jun 2007 Z-0718-2008 Unclassified (pre-2012) Terminated Incorrectly labeled-- Product has the wrong barcode labeling. The barcode error will not influence the results of testing. The instrument will discover the error and post an error notice. Distribution: Worldwide Distribution --- USA including states of OH, CA, NJ, NC, and countries of Japan, France, Switzerland, Spain,…
      Full distribution text Worldwide Distribution --- USA including states of OH, CA, NJ, NC, and countries of Japan, France, Switzerland, Spain, Italy, Germany, and the UK.
    • 29 Mar 2007 Z-1169-2007 Unclassified (pre-2012) Terminated Some product containers may be leaking. Distribution: Product was distributed to 3 US consignees in NJ, WA and TX, with one consignee in France.
    • 30 Jan 2007 Z-0723-2007 Unclassified (pre-2012) Terminated Some of the packaged tips have increased force during aspiration, which can lead to pipetting errors such as LLD error messages, and also has risk of causing a missed pipetting. Distribution: Nationwide (via a single distributor in New Jersey)

  • 2006

    • 28 Mar 2006 Z-1169-06 Unclassified (pre-2012) Terminated There is an error in the marking of the graduated divisions on syringes in affected lots that shows an amount that is double the actual volume of the syringe Distribution: Worldwide-The product was distributed to 28 U.S. consignees and 3 foreign consignees. (Canada, Switzerland, Japan)
Show all 13 recalls

  • 2006

    • 28 Mar 2006 Z-1170-06 Unclassified (pre-2012) Terminated There is an error in the marking of the graduated divisions on syringes in affected lots that shows an amount that is double the actual volume of the syringe Distribution: Worldwide-The product was distributed to 28 U.S. consignees and 3 foreign consignees. (Canada, Switzerland, Japan)

  • 2005

    • 13 Dec 2005 Z-0514-06 Unclassified (pre-2012) Terminated Heat sinking on power boards may not operate as intended and the board may cease to operate. Distribution: Product was released for distribution to 132 consignees in US, and 17 International consignees Submission number: K871945
    • 24 Aug 2005 Z-0087-06 Unclassified (pre-2012) Terminated The product valve has a high probability of deforming and may result in leakage during use. Distribution: One distributor and 8 consumers received this product in CA, MA, MI, WI, Japan and Switzerland.

Frequently asked questions

How many devices does Hamilton Co. have in the registry?

The registry currently lists 16 devices for Hamilton Co.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hamilton Co.'s devices?

Among its 16 most recently registered devices, Hamilton Co. has devices listed in FDA 510(k) (16 devices).

What risk classes do Hamilton Co.'s devices fall under?

Among its 16 most recently registered devices, the classes recorded for Hamilton Co.'s devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for Hamilton Co.?

FDA recall records list 13 recalls initiated by Hamilton Co., the most recent initiated on 2021-01-15. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Hamilton Co. in the registry?

The most recently registered devices listed for Hamilton Co. include DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER, MICROLAB P, PB 600 REPEATING DISPENSER and MULTI-PROBE HEAD PLUS.

Generated automatically from registry data and not verified by a human reviewer.