DG Gel 8 A/B/D 210384Recalls & reported problems
Diagnostic Grifols SA · The DG Gel 8 A/B/D card is for the determination of human A, B and D antigens on the surface of red blood cells of two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08437014205930), received between Sep 29, 2025 and Sep 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive Result” (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
- False Positive Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2025False Positive Result; False Positive Result
THE CUSTOMER REPORTED RH DISCREPANCIES IN TWO DIFFERENT PATIENT SAMPLES: SAMPLE (B)(6) (FEMALE PATIENT) TESTED ON (B)(6) 2025 USING DG GEL 8 A/B/D (LOT 25007.01), DG GEL 8 NEUTRAL (LOT 25003.1.1), AND REVERSE-CYTE A1, B (LOT 641425033). RESULT: RH POSITIVE (3+) PATIENT HISTORY: A NEGATIVE, NO TRANSFUSIONS, PREGNANT, RECEIVED RHOGAM ON (B)(6) 2025. SAMPLE (B)(6) (MALE PATIENT) TESTED ON (B)(6) 2025 WITH THE SAME REAGENTS AND LOTS AS THE OTHER SAMPLE, DG GEL 8 A/B/D (LOT 25007.01), DG GEL 8 NEUTRAL (LOT 25003.01), AND REVERSE-CYTE A1, B (LOT 641425033). RESULT: RH POSITIVE (2+) PATIENT HISTORY: O NEGATIVE, RECEIVED TWO UNITS OF O NEGATIVE BLOOD IN (B)(6) 2024. ON (B)(6) 2025, BOTH SAMPLES WERE RETESTED USING DG GEL 8 A/B/D (LOT 25009.01), AND BOTH SHOWED RH POSITIVE (3+) IN THE MICROTUBE D. ON (B)(6) 2025, THE SAMPLES WERE THEN TESTED USING THE DG GEL 8 ABO/RH (2D) CARD (LOT 25003.01), AND THE RESULTS OBTAINED FOR BOTH SAMPLES WERE ALSO POSITIVE (3+) IN THE TWO D WELLS. THIS CARD HAS THE SAME D CLONE AS THE DG GEL 8 A/B/D. FINALLY, BOTH SAMPLES WERE RETESTED USING TUBE TECHNIQUE WITH GRIFOLS ANTI-D REAGENT (LOT 029000), YIELDING NEGATIVE RESULTS (AS EXPECTED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23165981 ↗
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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