2022 Biologics Recalls
| Date Notification | Brand Name | Product Description | Reason/Problem | Company |
|---|---|---|---|---|
| January 14, 2022 | Urgent Voluntary Recall: CorneaGen Cornea/ Cornea Patch Grafts; CorneaGen is voluntarily recalling Corneal Patch Grafts bearing the following product numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103 | Product Numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103 | On January 5, 2022, CorneaGen discovered that Cornea Patch Grafts were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and were shipped prior to being medically cleared. Additional serology results found the donor to be non-reactive for HIV I/II NAT testing. CorneaGen is voluntarily recalling Corneal Patch Grafts bearing the following product numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103. | CorneaGen Seattle, WA |
| January 11, 2022 | Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338 | Lot Number: W419221008338 | On January 5, 2022, CorneaGen discovered that Scleral Patch Grafts (Lot Number WA419221008338) were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and HIV NAT, and were shipped prior to being medically cleared. CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338. | CorneaGen Seattle, WA |