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FDAJune 13, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

coopersurgical

UPCs

00815965020914

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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