Events

Recall of Device Recall SP Brand Strep A Cassette

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biosite Inc Dba Innovacon 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
    57715
  • Event Risk Class
    Class 2
  • Event Number
    Z-1395-2011
  • Event Initiated Date
    2011-01-12
  • Event Date Posted
    2011-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97073
  • 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
    Antigens, all groups, streptococcus spp. - Product Code GTY
  • Reason
    The recall was initiated after the investigation of customer-reported complaints, testing of market retention and returned product, it was determined that this lot of product has demonstrated an elevated incidence of non-specific binding, potentially causing false positive results. a false positive test result could lead to the administration of antibiotics that are unnecessary. this exposes the.
  • Action
    The firm, Alere San Diego, sent a "URGENT MEDICAL DEVICE RECALL" letter dated January 17, 2011. The letter described the product, problem and action to be taken by customers. The customers were instructed to: (1) Immediately discontinue use of the affected lot (if applicable) and inventory remaining full or partial kits at their site (if applicable); (2) Destroy any remaining inventory of this lot and document destruction per their site requirements (if applicable); (3) Complete and FAX the enclosed Verification Form within 10 days to confirm their receipt of this notice and to receive replacement of their remaining inventory of this lot (if applicable). The customers were ask to please return the form even if they have no remaining inventory or do not have any involved product in order to confirm receipt of this notification; and (4) to please ensure that all users of the device have received a copy of this Urgent Medical Device Recall. Customers with questions about the information contained in the notice were instructed to contact Technical Services at 888-246.7483, option 2 or by e-mail attechservices@alere.com.

Device

Device Recall SP Brand Strep A Cassette
  • Model / Serial
    Lot #: STA0010037
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution
  • Product Description
    SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 || The SP Brand Strep A Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.
  • Manufacturer
    Biosite Inc Dba Innovacon Inc.

Manufacturer

Biosite Inc Dba Innovacon Inc.
  • Manufacturer Address
    Biosite Inc Dba Innovacon Inc., 9975 Summers Ridge Rd, San Diego CA 92121
  • 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