RegenKit®-BCT-3 RK-BCT-3Recalls & reported problems
Regen Lab SA · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640138980411), received between Nov 13, 2019 and Nov 13, 2019 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DURING A BLOOD DRAW PROCEDURE FOR PREPARING PLATELET-RICH PLASMA (PRP), THE PHYSICIAN NOTICED THE TUBE FOR COLLECTING BLOOD HAD NOT ENOUGH VACUUM. HE STOPPED THE PROCEDURE. BY REMOVING THE FAULTY TUBE FROM THE TUBE HOLDER OF THE TRANSFER DEVICE, THE GLASS TUBE BROKE AND DOCTOR GOT CUT AT HIS THUMB. STITCHES WERE PERFORMED ON SITE BY ANOTHER DOCTOR AND HAVE HEALED WELL. PHYSICIAN WAS EXPOSED TO PATIENT BLOOD AS FEW ENTERED IN THE TUBE. THE PHYSICIAN RECOVERED WELL AND DID NOT WANT TO UNDERGO FURTHER BLOOD CONTAMINATION TESTING DUE TO BEING FAMILIAR WITH THE PATIENT MEDICAL HISTORY, DESPITE THE STRONG RECOMMENDATIONS OF THE MANUFACTURER TO CARRY OUT THE TESTS.
Patient problems: Laceration(s)
MAUDE report 9316561 ↗
Other Platelet And Plasma Separator For Bone Graft Handling devices
- Arthrex® ABS-10061TArthrex, Inc. · Platelet and plasma separator for bone graft handling75 reports
- Arthrex® ABS-10060RArthrex, Inc. · Platelet and plasma separator for bone graft handling66 reports
- Arthrex® ABS-10060Arthrex, Inc. · Platelet and plasma separator for bone graft handling59 reports
- Arthrex® ABS-10011Arthrex, Inc. · Platelet and plasma separator for bone graft handling51 reports
- Arthrex® ABS-10063Arthrex, Inc. · Platelet and plasma separator for bone graft handling49 reports
- Arthrex® ABS-10062TArthrex, Inc. · Platelet and plasma separator for bone graft handling35 reports
- Arthrex® ABS-10080Arthrex, Inc. · Platelet and plasma separator for bone graft handling9 reports
- Arthrex® ABS-2016-02Arthrex, Inc. · Platelet and plasma separator for bone graft handling7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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