Events

Recall of Device Recall Chemistry Wash1 REF 10680

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

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
    79264
  • Event Risk Class
    Class 2
  • Event Number
    Z-1149-2018
  • Event Initiated Date
    2017-11-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161792
  • 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
    Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
  • Reason
    The firm has initiated a field recall of the wash1 kit ref 10680 due to reported inconsistent lipase values when analyzing patient samples. the firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (trig) assay if they are on the same worklist.
  • Action
    Firm emailed all consignees and instructed them to remove/discard affected wedges (bottles) and contact Medica for immediate replacement 1 Immediately discontinue use of the Wash1 wedges (REF 10680) (Lot# listed above) and discard any remaining kits/wedges. 2. Please discuss possible concerns about lipase results achieved using these lots of Wash wedges with your laboratory manager and/or clinician in order to decide on appropriate measures. Report any concerns to Medica for evaluation and review. 3.Submit claims for replacement of affected product to your authorized Medica EasyRA dealer. For further questions, please call (781) 541-7560.

Device

Device Recall Chemistry Wash1 REF 10680
  • Model / Serial
    Lots 16279, 17045 and 17215
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide and US Distribution.
  • Product Description
    Wash Kit (REF 10680) Lots 16279, 17045 and 17215 || Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The major interferant for Lipase is the Triglycerides (TRIG) assay since one of the reagents contains lipase as an active ingredient.
  • Manufacturer
    Medica Corporation

Manufacturer

Medica Corporation
  • Manufacturer Address
    Medica Corporation, 5 Oak Park Dr, Bedford MA 01730-1430
  • Manufacturer Parent Company (2017)
    Medica Corporation
  • Source
    USFDA