Events

Recall of Device Recall Oral Fluid Drug Screen

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alere San Diego, 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
    66870
  • Event Risk Class
    Class 2
  • Event Number
    Z-0653-2014
  • Event Initiated Date
    2013-06-03
  • Event Date Posted
    2014-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123825
  • 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
    Oral Fluid Drug Screen Device - Product Code DKZ
  • Reason
    Alere initiated this recall of certain lots of the oral fluid drug screen device because the sponge may become dislodged from the saliva collector handle prior to or during the oral fluid sample collection process. if the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk.
  • Action
    Firm sent customers notification letter via combination of fax, email or direct mail. The notification letter dated June 3, 2013, titled "URGENT PRODUCT SAFETY NOTICE", informed customers of the recall, reason for recall, product description with lot codes, potential hazard statement, customer required actions, and contact information.

Device

Device Recall Oral Fluid Drug Screen
  • Model / Serial
    Lot/Unit Codes: DSD-765-011 (Alere PN 4012350099)  DOA2100709, DOA2110198, DOA2120093, DOA3010031, DOA3010095, DOA3010096, DOA3010393, DOA3010566, DOA3020420. DSD-765-011 (Alere PN 4080350099)  DOA2100672, DOA2120094, DOA2120095, DOA2120158, DOA3010013, DOA3010064, DOA3010097, DOA3010394, DOA3010565, DOA3020557. DSF-765-031 (Alere PN 4584150099)  DOA2100438, DOA2100667, DOA2110073, DOA2110315, DOA2120096, DOA2120738, DOA2120739, DOA3010003, DOA3010004, DOA3010005, DOA3010199, DOA3010202, DOA3020182, DOA3020183. DSF-765-011 (Alere PN 4582290164)  DOA2100250, DOA2110316 , DOA2110317 , DOA2120502, DOA2120503, DOA3010236. DSF-765-011 (Alere PN 4028220211)  DOA2100614.  Expiration date, or Expected shelf life: 10/31/14 to 2/28/15. Expected shelf life: 24 months.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution: including states of: AL, CA, PA, and VA.
  • Product Description
    Product Brand Name(s): || Innovacon Oral Fluid Drug Screen Device, || OrALert Oral Fluid Drug Screen Device, || OrALert Oral Fluid Drug Screen Device with BZO, || Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. || Type of Packaging: 25 individually pouched test devices & collectors in a labeled || kit box. || The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an || immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid || specimen compete against their respective drug conjugates for binding sites on their specific antibody.
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • Manufacturer Address
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA