Events

Recall of Device Recall ELaCL AntiCardiolipin ELISA Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thera Test 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
    34945
  • Event Risk Class
    Class 3
  • Event Number
    Z-0835-06
  • Event Initiated Date
    2006-01-11
  • Event Date Posted
    2006-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44985
  • 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
    System, Test, Anticardiolipin Immunological - Product Code MID
  • Reason
    The specimen diluent contained in the kits was contaminated with a fungal growth. also, a portion of kit lot 09055514 was shipped without the data sheet, part #201-204.
  • Action
    On 10/26/05, Thera Test telephoned the 3 accounts who received lot 09055514 without the Data Sheet in the kits, and sent them copies of the Data Sheet for insertion into the 6 kits on hand at the consignees. Between 1/4-9/06, Thera Test telephoned the 17 accounts receiving kit lots 09055514 and 12055603, and sent them follow-up letters dated 1/9/06 with replacement bottles of Specimen Diluent. The accounts were advised of the fungal contamination found in some bottles of the diluent shipped with the kit lots, and were requested to destroy any remaining bottles of the Specimen Diluent in their kits and replace them with the bottles of diluent sent with the letter.

Device

Device Recall ELaCL AntiCardiolipin ELISA Kit
  • Model / Serial
    catalog #201-204:  kit lot 09055514, exp. 14-JUL-2006, serum diluent lot 09055546, exp 04-OCT-2006; and kit lot 12055603, exp. 09-NOV-2006, serum diluent lot 11055595, exp. 18-NOV-2007
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, Connecticut, Maryland, Pennsylvania, Ohio, New Jersey and Florida.
  • Product Description
    EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148
  • Manufacturer
    Thera Test Laboratories, Inc.

Manufacturer

Thera Test Laboratories, Inc.
  • Manufacturer Address
    Thera Test Laboratories, Inc., 1111 N Main St, Lombard IL 60148-1360
  • Source
    USFDA