Z-1044-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2023
- Initiation Date
- December 15, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 489 units
Product Description
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
Reason for Recall
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.
Distribution Pattern
Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt, France, Georgia, Greece, Hong Kong, Iran, Iraq, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Nigeria, Oman, Pakistan, Poland, Republic of North Macedonia, Saudi Arabia, Slovenia, Spain, Thailand, Turkey, Turkmenistan, and United Arab Emirates.
Code Information
Lot Number: 220506-006557