Device Recall SpermMar 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

Immunology and Microbiology Devices

1

No

US Distribution to the state of : OR., and Internationally to Argentina.

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.