CLASS II Device recall · Reported 22 Apr 2015 · FDA Enforcement Report
SpermMar Test Beads Particles Label on bottle recalled by Vitrolife
Vitrolife is recalling SpermMar Test Beads Particles Label on bottle: SpermMar Test IgA Beads/Particles-50 Tests, distributed nationwide in the US. The recall was initiated on 22 Dec 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1448-2015
- FDA event ID
- 70131
- Recalling firm
- Vitrolife, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Dec 2014
- FDA classified
- 15 Apr 2015
- Reported
- 22 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Dec 2014 | Recall initiated by company | |
| 15 Apr 2015 | Classified by FDA | +114 days |
| 22 Apr 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to the state of : OR., and Internationally to Argentina.
Questions about this recall
Is SpermMar Test Beads Particles Label on bottle: SpermMar Test IgA Beads/Particles-50 Tests recalled?
Yes. Vitrolife recalled SpermMar Test Beads Particles Label on bottle: SpermMar Test IgA Beads/Particles-50 Tests on 22 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-1448-2015.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US Distribution to the state of : OR., and Internationally to Argentina.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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