Events

Recall of Device Recall SickleSTAT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Chembio Diagnostic System 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
    34263
  • Event Risk Class
    Class 3
  • Event Number
    Z-0470-06
  • Event Initiated Date
    2005-12-16
  • Event Date Posted
    2006-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43381
  • 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
    Test, Sickle Cell - Product Code GHM
  • Reason
    Firm received one report of a false negative with the positive control. internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.
  • Action
    Chembio phoned the consignees and followed up by faxing the recall letters (dated 12/15/05) & response forms on 12/22/05.

Device

Device Recall SickleSTAT
  • Model / Serial
    Lot SC050305, exp. 31OCT06; Lot SC062805, exp. 30NOV06
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Medical facilities and a few distributors located nationwide, the Dominican Republic, and West Indies (St. Vincent & Grenadine)
  • Product Description
    Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled Sickle-STAT reaction tubes containing sodium hydrosulfite. 1 bottle phosphate buffer containing surfactant and stabilizer, and 1 Instruction leaflet. --- manufactured by: CHEMBIO DIAGNOSTIC SYSTEMS, INC., MEDFORD, NY 11763 --- Accessories available: SC902: Sickle-STAT 5-place Observation rack, SC903: Sickle-STAT Hemoglobin S Control Set; 4 x 1 vials: 2 A/A negative and 2 A/S positive, SC904: Sickle-STAT Phosphate Buffer, 200 ml.
  • Manufacturer
    Chembio Diagnostic System Inc

Manufacturer

Chembio Diagnostic System Inc
  • Manufacturer Address
    Chembio Diagnostic System Inc, 3661 Horseblock Road, Medford NY 11763-2215
  • Source
    USFDA