Events

Recall of Device Recall Hemoglobin Test Kits

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

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
    29485
  • Event Risk Class
    Class 2
  • Event Number
    Z-1158-04
  • Event Initiated Date
    2004-06-29
  • Event Date Posted
    2004-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33827
  • 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
    System, Analysis, Electrophoretic Hemoglobin - Product Code JBD
  • Reason
    Hemoglobin test kit catholyte solution generating false positive results, were distributed.
  • Action
    The firm contacted their customers via telephone and notified them of the recall on 6/29/2004. A follow-up recall letter was also issued on 6/29/2004. The letter requests that the customer either destroy the product or return it to the firm for replacement. Also attached for completion and to be faxed back to the recalling firm, is a questionaire which documents the customer''s receipt of the product and recall letter; any reports of illness or injury in connection with the use of the product; and the customer''s proposed disposition of the kits i.e. return or destruction. Additional follow-up with all non-responding customers will take place in 2 weeks.

Device

Device Recall Hemoglobin Test Kits
  • Model / Serial
    Catholyte Solution Batch Lot #235867, included in kits labeled with Kit Lot Numbers: 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234222, 234231, 234240, 234247, 234252, 234257, 234262, 234267, 234272, 234277, 238917, 238920 & 238923.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled kits were distributed to customers in the following locations: FL, OK, GA, MD, AZ, KY, NY, PR, OR, NJ, WA, MI, KS, AR, IN, TX, MN, CA, VA, NC, DE, UT, WI, SC, OH, MT, KS, CO & PR.
  • Product Description
    RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.
  • Manufacturer
    PerkinElmer LAS Inc

Manufacturer

PerkinElmer LAS Inc
  • Manufacturer Address
    PerkinElmer LAS Inc, 3985 Eastern Rd, Norton OH 44203-6215
  • Source
    USFDA