Device recall
Z-1448-2015: SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml…
FDA device recall · Class II · Vitrolife Inc
Key facts
| Recall number (Z-number) | Z-1448-2015 |
|---|---|
| Recall event | 70131 |
| 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… |
| Product code | KTO |
| Recalling firm | Vitrolife Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 5, 2015 |
| FEI number | 3002757762 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database