ThromboType®Recalls & reported problems
Immucor Gti Diagnostics, Inc. · ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15 (Gov), using PCR amplification of human genomic DNA. · Class 2
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 10888234500285), received between Jun 29, 2018 and Jun 29, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (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.
Most reported problems
Device problems
- Device Ingredient or Reagent Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2018Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
THROMBOTYPE LOT 3005154 (EXPIRATION DATE 08-15-2018) FAILED TO MEET TESTING SPECIFICATIONS DURING 15-MONTH STABILITY TESTING DUE TO WEAK AND/OR ABSENT BANDS IN THE HPA-1A AND HPA-3A SYSTEMS DURING THE INITIAL TESTING ON 05/30/2018. THE FAILURE MODE OBSERVED IN OOS 18-98 WAS CONFIRMED DURING REPEAT TESTING. OOS 18-98 WAS INITIATED TO INVESTIGATE WEAK AND/OR ABSENT BANDS IN THE HPA-1A AND HPA-3A SYSTEMS DURING REPEAT TESTING ON (B)(6) 2018. ALTERNATE SAMPLES WERE TESTED UNDER OOS 18-98, TO RULE OUT SAMPLE INTEGRITY. THE REPLACEMENT SAMPLES SHOWED WEAK/ABSENT BANDS FOR HPA-1A AND ABSENT BANDS FOR HPA-3A. THE FAILURES WERE ISOLATED TO THE HPA-1A AND HPA-3A SYSTEMS INDICATING THAT THE OTHER TEST KIT COMPONENTS ARE PERFORMING AS EXPECTED. THIS INDICATES POTENTIAL DEGRADATION OF THE HPA-1A AND HPA-3A PRIMERS. A REVIEW OF SIMILAR PRODUCTS IN THE FIELD IDENTIFIED THROMBOTYPE 1 LOTS 3006502 AND 3005160. THROMBOTYPE 1 LOT 3005160 WAS MANUFACTURED WITH THE SAME LOTS OF PRIMER RAW MATERIALS FOR THE HPA-1A SYSTEM. THE 18 MONTH STABILITY TIME POINT WAS COMPLETED ON 06/19/2018 AND ALL SPECIFICATIONS WERE MET. THEREFORE, THIS FAILURE APPEARS TO BE SPECIFIC TO THE MANUFACTURE OF THE THROMBOTYPE LOT
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7652289 ↗
Other Test,Platelet Antibody devices
All Test,Platelet Antibody devices →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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