Devices

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.
  • 1 Event

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