PAXGENE® BLOOD RNA TUBE
Received Jun 4, 2026 · Event occurred May 7, 2026
Report 9617032-2026-00997 · MDR key 25401339
Device
Generic name
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular
Manufacturer
Preanalytix GmbhCatalog number
762165
Lot number
5351098
Product problems
- Material Fragmentation
- Device Markings/Labelling Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
G.4. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: PMA / 510(K)#: K082150. BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE INDICATED FAILURE MODE OF A MISSING LABEL WAS OBSERVED IN THE PHOTO HOWEVER; TRAY PACK RESIDUE WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: MISSING LABEL. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: TRAY PACK RESIDUE. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING PAXGENE® BLOOD RNA TUBES, ONE (1) TUBE WAS MISSING A LABEL, WHICH WAS FOUND ADHERED TO ANOTHER TUBE. ADDITIONALLY, LOOSE STYROFOAM PARTICLES WERE PRESENT IN THE TRAY AND WERE OBSERVED TO ELECTROSTATICALLY ADHERE TO THE BOTTOMS OF THE TUBES UPON REMOVAL. THERE WAS NO REPORTED HEALTH IMPACT OR ADVERSE CONSEQUENCE.