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OriGen Biomedical, Inc. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a Class IIDec 19, 2023Accessory sets contain a syringes not yet qualified for the
Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and cClass IIIJan 28, 2021It was identified that tissue culture bags were incorrectly

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