KJGClass I

Tube, Tissue Culture

Pathology · 21 CFR 864.3010

MDR events29All time

Recalls1All time

Registered firms36Currently listed

510(k) clearances1All time

Recent MDR events

29 adverse event reports on file

Event type breakdown

Malfunction28

Injury1

Most-reported manufacturers

Citotest Labware Manufacturing Co.,23 Origen Biomedical, Inc.3 Origen Biomedical2 B. Braun Medical Inc.1

Recalls

1 recall events for this product code

OriGen Biomedical, Inc.
Open, ClassifiedFeb 9, 2024
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing,
Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes.
Z-1068-2024 · View FDA record ↗

Registered firms

36 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

Corning Medical & ScientificJan 5, 1983
K823747 · 24 CELL WELLS TISSUE CULTURE