GPS® III Platelet Concentration System 800-1003ARecalls & reported problems
Biomet Biologics, LLC · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304681491), received between Jun 5, 2020 and Jul 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare1
- Inadequate Filtration Process1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2025Inadequate Filtration Process; Inadequate Filtration Process
IT WAS REPORTED THAT DURING A PROCEDURE, THE CLINIC ATTEMPTED TO DO A PRP BUT ENCOUNTERED A DOUBLE BUFFY LAYER. THEY OPTED NOT TO INJECT THE PRP BACK INTO THE JOINT BECAUSE THEY WERE UNSURE IF THE DOUBLE BUFFY LAYER WOULD HAVE ANY CLINICAL IMPACT ON THE EFFICACY OF THE PRP PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586609 ↗MalfunctionJun 5, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10122632 ↗
Other SUPPLIES, BLOOD-BANK devices
- Capture-P Indicator Red Cells 0066240Immucor, Inc. · Supplies, Blood-Bank2 reports
- Capture-P 0066251Immucor, Inc. · Supplies, Blood-Bank1 report
- Capture-P 0066246Immucor, Inc. · Supplies, Blood-Bank1 report
- TERUMO SAMPLING SITE COUPLER TC*MP1Terumo Corporation · Supplies, Blood-Bank1 report
- Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum 0066905Immucor, Inc. · Supplies, Blood-Bank1 report
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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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