Events

Recall of Sure Check hCG Cassette Pregnancy Test

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
    30288
  • Event Risk Class
    Class 2
  • Event Number
    Z-0277-05
  • Event Initiated Date
    2004-10-06
  • Event Date Posted
    2004-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35617
  • 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
    Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
  • Reason
    Poor sealing of pouches and degradation of products. firm received an e-mail from a distributor of an increase in complaints. in response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of the two lots. chembio's investigation revealed invalid results (no control lines) and some false negatives.
  • Action
    Recall letters on 10/6/04, followed by a second letter on/about 10/20/04. Recall letters mailed on 11/9/04 to cover recall expansion for 4 additional lots.

Device

Sure Check hCG Cassette Pregnancy Test
  • Model / Serial
    Lot U040904 (Exp. 30 SEP 06) ; Recall Expansion: lot U032904/1 (Exp. 30 AUG 06 - 14,364 units distributed)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributors in KS, TN, NC, MA, NY, KY, FL, NV, and Puerto Rico for further distribution to their retail customers. Products also distributed to accounts in Barbados WI, Israel, Costa Rica and Canada.
  • Product Description
    OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti-¿ hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A.
  • 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