| 2023-11-02 |
Class II
|
Ongoing |
Z-0998-2024 |
Sperm separation media are used to separate motile sperm from other constituents of semen. |
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The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life:… |
| 2023-01-16 |
Class II
|
Ongoing |
Z-1314-2023 |
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 |
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Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products. |
| 2021-09-08 |
Class II
|
Ongoing |
Z-0249-2022 |
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (M… |
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Due to a component in kit being labeled with the incorrect Expiration Date |
| 2021-09-08 |
Class II
|
Ongoing |
Z-0248-2022 |
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (M… |
— |
Due to a component in kit being labeled with the incorrect Expiration Date |