Recall Z-0248-2022 ยท MQL Media, Reproductive
Fujifilm Irvine Scientific, Inc.
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the V
| Date | Sep 8, 2021 |
| Status | Open, Classified |
| Reason | Due to a component in kit being labeled with the incorrect Expiration Date |
| Root cause | Software design |
| Action | On September 09, 2021, the firm, Fujifilm, sent Customer notification letter via e-mail to customers (direct) and Distributors under heading "Notice: Product Labeling Information", notifying customers of the components in a kit may be labeled with an incorrect expiration date. The firm determined that the product is safe to use, however, customer to follow the expiration date on the kit label and of Certificate Of Analysis, which had shorter expiration date than the affected products expiration date. Two product types had incorrect expiration date. The customer data collection form sent to th |
| Quantity | 677 units or kits of 90133-DSOC210605 (9 x 1ml per kit); 595 kits in U.S. and 82 kits OUS |
| Distribution | Worldwide Distribution: U.S. (nationwide) to states of: AL, AK, AZ, CA, CT, DE, FL, ID, IL, IN, ND, NC, NV, NY, NJ, NE, OH, OK, OR, PA, SC, SD, MA, MS, MI, MO, MD, MN, TN, TX, UT, VA, VT, WI, WV and OUS (international) to countries of: Brazil, EU, Canada, India, South Korea, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vi Irvine Scientific, May 4, 2016 |