Z-1448-2015Class II

SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF...

Name: Z-1448-2015 SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF...
Creator: Vitrolife Inc
Published: 2014-12-22
License: https://open.fda.gov/license/

Vitrolife Inc. / initiated 2014-12-22 / Terminated / root cause: design

FDA source

Vitrolife Inc began a recall of 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... on 2014-12-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1448-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-22
Posted: 2015-04-15
Terminated: 2015-05-05
Recalling firm: Vitrolife Inc.
Product: 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.
Product code: KTO Reagent, Immunoassay, Igg
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 45 kits
Distribution: US Distribution to the state of : OR., and Internationally to Argentina.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1448-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1448-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-22	2015-04-15

Product code KTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)