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  5. 2022 Biologics Recalls
  1. Recalls (Biologics)

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
 
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