Events

Recall of Device Recall SpermMar Test

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vitrolife 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
    70131
  • Event Risk Class
    Class 2
  • Event Number
    Z-1448-2015
  • Event Initiated Date
    2014-12-22
  • Event Date Posted
    2015-04-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132286
  • 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
    Reagent, immunoassay, igg - Product Code KTO
  • Reason
    The firm is recalling three batches (fp14a09, fp14a10, fp14a11) of spermmar iga test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added.
  • Action
    FertiPro sent an Urgent: Medical Device Recall letter dated December 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to check if they have stock of the concerned lots and provide a confirmation that they have destroyed the affected products. Distributors were asked to inform their customers and instruct them to do the same. For further questions you may call (858) 824-0888.

Device

Device Recall SpermMar Test
  • Model / Serial
    Manufacturer's Product Number/Catalog Number: SPMA_S  Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of : OR., and Internationally to Argentina.
  • Product Description
    SpermMar Test || 0.7ml Beads Particles || Label on bottle: || SpermMar Test IgA || 0.7ml Beads/Particles-50 Tests || IND REF SPMA_S || LOT Expiration || DO NOT FREEZE/NE PAS CONGELER || FertiPro N.V. || Label on box: || SpermMar || Test || IGA || 50 Determination || Test Kit || CONTENTS || 1 vial SpermMar Latex Particles 0.7 ml || REF SPMA_S || FertiPro || FertiPro N.V. || Label on box: || SpermMar || Test || IgA || 50 Determination Test Kit || Contents: 1 vial SpermMar latex particles, 0.7ml || FertiPro N.V. || For In Vitro Diagnostic || Use || SpermMar IqA Test || Manufacturer's Product Number/Catalog Number: SPMA_S || Lot/Serial Number Expiration Date || FP14A09 02/29/2016 || FP14A10 04/30/2016 || FP14A11 04/30/2016 || Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
  • Manufacturer
    Vitrolife Inc

Manufacturer

Vitrolife Inc
  • Manufacturer Address
    Vitrolife Inc, 6835 Flanders Dr Ste 500, San Diego CA 92121-3927
  • Manufacturer Parent Company (2017)
    Vitrolife AB
  • Source
    USFDA