FDA recall Z-1421-2022

Product

LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055

Reason for recall

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2022-06-13

Report date

2022-07-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Trumbull, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1421-2022