Events

Recall of Device Recall COBAS AmpliPrep Sample Input Barcode Clips

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
    62586
  • Event Risk Class
    Class 2
  • Event Number
    Z-2209-2012
  • Event Initiated Date
    2012-02-01
  • Event Date Posted
    2012-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111094
  • 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
    Analyzer, chemistry, micro, for clinical use - Product Code JJF
  • Reason
    Certain lots of cobas ampliprep (cap) s-tube input (box of 12 bags 12x24 s-tube and 12x24 s-clip) can cause the sample input tubes to stick in the barcode clips. as a consequence, the cap instrument will lift both the sample input tube together with the barcode clip from the sample rack, resulting in an aborted run. no erroneous results would be produced if the issue occurs, but samples in proce.
  • Action
    On 1/17/2012 an "Analyzer Bulletin" notification was sent to Roche affiliates and on 2/1/2012 an "Analyzer Bulletin" notification was sent to all affected US Consignees. The notification described the product issue and provided recommended actions. Customers were referred to Roche Technical Support at 800-526-1247 for questions.

Device

Device Recall COBAS AmpliPrep Sample Input Barcode Clips
  • Model / Serial
    Lot Numbers: 11049503, 11053503, 11054503, 11525503 and 11526503.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA).
  • Product Description
    COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

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