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FDADecember 15, 2022device

BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)

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

The hazard

The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.

What to do

FDA enforcement status: Ongoing

Brands named

coopersurgical

UPCs

220506006557

Recall history

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

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