Events

Recall of Disposable Syringe Pack for use with Microlab F.A.M.E

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hamilton Co.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60047
  • Event Risk Class
    Class 3
  • Event Number
    Z-0103-2012
  • Event Date Posted
    2011-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104305
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    Certain lots of syringes have caused an increase in error message "dis541", which indicates "improper dispensation".
  • Action
    The firm, Hamilton, sent an "Urgent: Product Recall Notification" letter dated September 26, 2011 to its customers. The letter describes the product, problem and action to be taken. The customers were instructed to return the syringes with a completed Hamilton Company Product Recall Questionnaire form via fax to: (775) 856-7259 or with an emailed signed pdf copy to wayne.mcauliffe@hamiltoncompany.com. The firm's Customer Service Department will contact customers with complete Returned Material Authorization information. If you have any questions, please do not hesitate to contact the Director of Quality at (775) 858-3000.

Device

Disposable Syringe Pack for use with Microlab F.A.M.E
  • Model / Serial
    Lots: 30311; 50411; 30511; 50611; 50711; 50811; 30911; 50911; 51011; 31111; 51111;31211; 51211; 31311; 51311
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA(nationwide) including states of: NJ, NV, TX and WA; and countries of: Brazil, P.R. China, France and Germany.
  • Product Description
    Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV || The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.
  • Manufacturer
    Hamilton Co

Manufacturer

Hamilton Co
  • Manufacturer Address
    Hamilton Co, 4970 Energy Way, Reno NV 89502-4123
  • Source
    USFDA