Devices

Device Recall AccuProbe GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST

  • Model / Serial
    Lots (batches): 554077, 551345, 556007, 556185, 555368, 554864, 556421, 555167, 555096, 555166, 556184, and 554524 (Internationally): 554076, 555622
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong Kong, Mali, Singapore, Bermuda, India, Mexico, South Africa, Canada, Israel, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines.
  • Product Description
    Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.
  • Manufacturer
    Gen-Probe Inc
  • 1 Event

Manufacturer

Gen-Probe Inc
  • Manufacturer Address
    Gen-Probe Inc, 10210 Genetic Center Dr, San Diego CA 92121
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Accuprobe Group B Streptococcus Culture Identification Test,
  • Model / Serial
    Catalog Number 2820B; Lot Number 531379
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide: including states of AZ, CA, CO, FL, KY, MD, MO, NC, NJ, TX, and UT
  • Product Description
    Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
  • Manufacturer
    Gen-Probe Inc