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U.S. Department of Health and Human Services

Class 2 Device Recall Vitrification Freeze kit

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  Class 2 Device Recall Vitrification Freeze kit see related information
Date Initiated by Firm September 08, 2021
Create Date November 17, 2021
Recall Status1 Open3, Classified
Recall Number Z-0249-2022
Recall Event ID 88720
510(K)Number K160006  
Product Classification Media, reproductive - Product Code MQL
Product 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 VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-SO Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 2 x 1 mL Equilibration Solution- ES; 2 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD
Code Information Catalog number: 90133-SO Vitrification Freeze kit Lot/Unit numbers: 90132210403; UDI # 00893727002811 Product code MLQ
Recalling Firm/
Manufacturer		 Fujifilm Irvine Scientific, Inc.
2511 Daimler St
Santa Ana CA 92705-5533
For Additional Information Contact Marlin Frechette
949-261-7800 Ext. 288
Manufacturer Reason
for Recall		 Due to a component in kit being labeled with the incorrect Expiration Date
FDA Determined
Cause 2		 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 the customer of the actions to be taken by customer/end user to fill out and send the acknowledgement form if they had affected products or did not have affected products and the quantity consumed or remained in inventory and mail the acknowledgement via e-mail. The firm revised the Customer Notification letter as "Urgent: Medical Device Correction-Supplemental Information" with the Placard to customers via USPS and informed Distributors to send Notification to their customers. The customers will be asked to: - follow the expiration date on the product kit label and Certificate of Analysis - check their inventory for affected product - inform their staff of the contents of the Notification letter - place the Placard near their affected inventory - contact the firm if they prefer to return and/or replace their affected inventory. The firm provided contact information as: fisira@fujifilm.com 24/7, or by phone at 1 (949) 261-7800 The firm asked their customers in revised data collection form and added Product Information, to notify the firm on # of kits received, # of kits consumed and # of kits remaining in inventory. The Quality Assurance placed the affected lots on "cease distribution" until the firm completes an investigation.
Quantity in Commerce 3981 units of Vitrification Freeze Kit 90133-SO210605; 314 kits in U.S. and 3667 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MQL and Original Applicant = Irvine Scientific
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