Z-1448-2015 Class II Terminated

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.

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.

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