Events

Recall of Device Recall COBAS Ampliprep/COBAS TaqMan HBV v2.0 USIVD COBAS Ampliprep/COBAS TaqMan HBV v2.0 CEIVD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Molecular Systems, 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
    57560
  • Event Risk Class
    Class 2
  • Event Number
    Z-1459-2011
  • Event Initiated Date
    2010-12-28
  • Event Date Posted
    2011-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96601
  • 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
    Hepatitis viral b dna detection - Product Code MKT
  • Reason
    There is an issue regarding liquid level detection of the cs1 magnetic glass particles (mgp) reagent cassette of the cobas ampliprep /cobas taqman hbv v2.0 test on the cobas ampliprep instrument.
  • Action
    Roche sent Urgent Medical Device Correction Letters to their consignees on December 28, 2010 via Fed Ex. The letters advise the customers to verify the correct configuration of the CSI reagent cassette, remind customers to follow the package insert instructions for including all required controls for each batch and advise that review of previously generated results may be warranted. A UMDC Faxback form was attached for the consignee to complete. For questions regarding this recall call 908-253-7569.

Device

Device Recall COBAS Ampliprep/COBAS TaqMan HBV v2.0 USIVD COBAS Ampliprep/COBAS TaqMan HBV v2.0 ...
  • Model / Serial
    Catalog number 05027012190, 05393850190, 05393850190, 05393868190 Lot #K11236, K15440, L00846, M05135, M11190, M12625, M14232, N00159, N02341, N05553, N05554, N07543, N08567
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CT, IN, MI, MN, NC, NE, NY, OR, TX, WA, and WI and the countries of Australia, Austria, Azerbaijan, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mauritania, Mongolia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and the United Kingdom
  • Product Description
    COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; || COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • Manufacturer Address
    Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Somerville NJ 08876-3733
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA