Device product
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Z-1421-2022
Product summary
- Event
- Event 90469
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 403 units
- Official record key
device-enforcement:Z-1421-2022
Official wording
Reason: There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.
Code information: UDI: (01)00815965020914 (17)220819 (10)GFT5-200218U (01)00815965020914 (17)220819 (10)GFT5-201026U (01)00815965020914 (17)220819 (10)GFT5-21335060 Lots: 21335060, GFT5-200218U, GFT5-201026U
Distribution pattern: Domestic: USA AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VT, WA, WI, International: Belgium, Canada, Croatia, Netherlands, Portugal, Spain
Derived failure modes
-
Unknown
There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.