Events

Recall of Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories 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
    37334
  • Event Risk Class
    Class 2
  • Event Number
    Z-0722-2007
  • Event Initiated Date
    2007-01-30
  • Event Date Posted
    2007-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50375
  • 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
    in vitro diagnostic - Product Code CEO
  • Reason
    Patient results are falsely decreased by up to 15% at these levels: 1) serum plasma phosphorus greater than 8.0 mg/dl (2.60 mmol/l) 2) urine phosphorus greater than 80.0 mg/dl (25.80 mmol/l).
  • Action
    A Product Correction letter dated January 30, 2007 provided to all Clinical Chemistry Phosphorus customers that have received lot numbers 42020HW00 and 44037HW00 stating that patient results are falsely decreased by up to 15% at these levels: Serum/Plasma phosphorus greater than 8.0 mgldL (2.60 mmol/L) and Urine phosphorus greater than 80.0 mg/dl. (25.80 mmol/L). Modified linearity ranges are provided in the letter that are to be implemented when using the two lots. Instructions are also provided for changing the linearity range on the Architect cSystem as well as the Aeroset System. Customers are instructed that If they have forwarded any of Information the Clinical Chemistry Phosphorus lots listed above to another laboratory to provide a copy of this letter to them. A customer response form is provided.

Device

Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
  • Model / Serial
    42020HW00 & 44037HW00
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, Jamaica
  • Product Description
    Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

Abbott Laboratories Inc.
  • Manufacturer Address
    Abbott Laboratories Inc., 820 Mission St, South Pasadena CA 91030-3142
  • Source
    USFDA