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Vit Kit-Freeze is intended for use in assisted reproductive… recallZ-0249-2022 · Fujifilm Irvine Scientific, Inc. · initiated Sep 8, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fujifilm Irvine Scientific, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to a component in kit being labeled with the incorrect Expiration Date

FDA root cause category: Software design

What the company is doing

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: [email protected] 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.

Recall details

Recall number
Z-0249-2022
Status
Open, Classified
Initiated by the company
Sep 8, 2021
Recalling firm
Fujifilm Irvine Scientific, Inc.
Quantity
3981 units of Vitrification Freeze Kit 90133-SO210605; 314 kits in U.S. and 3667 OUS
Product code
MQL
FDA submissions
K160006
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.

Product description

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 (models, lots, serial numbers)

Catalog number: 90133-SO Vitrification Freeze kit Lot/Unit numbers: 90132210403; UDI # 00893727002811 Product code MLQ

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 88720).

Sources and updates

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