PAXgene® Blood DNA Tube 761165Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04053727611659), received between Jun 3, 2019 and Jan 21, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (4 reports).

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

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USING PAXGENE® BLOOD DNA TUBE, A YELLOWISH DEPOSIT WAS SEEN AT THE BOTTOM OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132917 ↗
• MalfunctionOct 23, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT PRIOR TO USING PAXGENE® BLOOD DNA TUB, A PALE-YELLOW COAGULATION WAS SEEN INSIDE OF TWO TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367203 ↗
• MalfunctionMar 10, 2025Material Discolored; Material Discolored

  IT WAS REPORTED WHILE USING PAXGENE® BLOOD DNA TUBE, THE BODY OF ONE (1) TUBE IS A PALE BLUE SHADE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21567854 ↗
• MalfunctionJan 16, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USING PAXGENE® BLOOD DNA TUBE, 1205 TUBES DISPLAYED A DIFFERENT LOT NUMBER THAN THAT OF THE BOX THEY WERE PACKAGED IN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169069 ↗
• MalfunctionDec 13, 2024Component Missing; Component Missing

  IT WAS REPORTED BEFORE USING THE PAXGENE® BLOOD DNA TUBE THERE WAS MISSING ADDITIVE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924584 ↗
• MalfunctionNov 19, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING PAXGENE® BLOOD DNA TUBE THAT ONE (1) TRAY CONTAINED TUBES WITH TWO DIFFERENT BATCH NUMBERS AND EXPIRATION DATES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725064 ↗
• MalfunctionOct 15, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BEFORE USING THE PAXGENE® BLOOD DNA TUBE THERE WAS A BATCH NUMBER MISMATCH BETWEEN THE SHELF PACK LABEL AND THE TUBE LABEL. THE EVENT AFFECTED 800 TUBES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20458107 ↗
• MalfunctionOct 2, 2024Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  IT WAS REPORTED PRIOR TO USING PAXGENE® BLOOD DNA TUBES THAT 300 TUBES HAD A TUBE LABEL BATCH NUMBER DIFFERENT TAN THE SHELF PACK LABEL. ADDITIONALLY THERE WERE A MIX OF TWO BATCH NUMBERS WITHIN TWO SHELF PACKS. THERE WERE NO HEALTH IMPACTS OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353008 ↗
• MalfunctionSep 27, 2024Inaccurate Information; Inaccurate Information

  IT WAS REPORTED PRIOR TO USING PAXGENE® BLOOD DNA TUBES THAT TWO (2) SHELF PACK LABELS HAD A DIFFERENT BATCH NUMBER THAN THE TUBE LABELS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20325468 ↗
• MalfunctionSep 14, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD DNA TUBE THERE WAS MISSING ADDITIVE. THIS EVENT AFFECTED 103,550 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PRODUCT IS PRESENTING LOW YIELD. MOST SAMPLES FAILING DNA EXTRACTION QC ARE FAILING CONCENTRATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15421875 ↗
• MalfunctionJul 8, 2022Short Fill; Short Fill

  IT WAS REPORTED WHILE USING PAXGENE® BLOOD DNA TUBE DRAW VOLUME IS VERY SHORT. THIS EVENT OCCURRED 48 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ALLEGES THAT FOR PRODUCT CAT NO 761165 THE DRAW VOLUME IS VERY SHORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14962356 ↗
• MalfunctionJul 8, 2022Short Fill; Short Fill

  IT WAS REPORTED WHILE USING PAXGENE® BLOOD DNA TUBE DRAW VOLUME IS VERY SHORT. THIS EVENT OCCURRED 7 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ALLEGES THAT FOR PRODUCT CAT NO 761165 THE DRAW VOLUME IS VERY SHORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14962324 ↗
• MalfunctionApr 12, 2022Material Discolored; Material Discolored

  IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD DNA TUBE THERE WAS DISCOLORED/ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE "OBSERVED COLOR CHANGES IN THE TUBES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14090234 ↗
• MalfunctionJul 1, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD DNA TUBE, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 100 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: TUBES DON'T FILL CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104491 ↗
• MalfunctionMar 16, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED AFTER USE THE PAXGENE® BLOOD DNA TUBE HAD ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLOOD IS FRACTIONATION, CUSTOMER INVERTS 10 TIME AFTER COLLECTION AND THEN LETS IT SIT FOR 72 HOUR THEN INVERTS THE BLOOD 8-10 TIME BEFORE FREEZING.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9837186 ↗
• MalfunctionJun 3, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT PAXGENE® BLOOD DNA TUBE WAS EXPERIENCING LOW DRAW. THIS OCCURRED ON 2 OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 761165, BATCH NO: 8164968 IT WAS REPORTED THE TUBE IS NOT WORKING AS THE VACUUM SEAL CREATED BETWEEN THE TUBE AND THE VACUTAINER APPEARS TO BE VERY WEAK. THE LOT NUMBER FOR BOTH THE OPENED, DYSFUNCTIONAL TUBES, AND THE UNOPENED TUBE PACKAGE THAT WE HAVE IS THE SAME. IT IS 8164968. THIS IMPLIES TO ME THAT THE UNOPENED PACKAGE WOULD NOT WORK EITHER. THE TUBE IS NOT WORKING FOR US AS THE VACUUM SEAL CREATED BETWEEN THE TUBE AND THE VACUTAINER APPEARS TO BE VERY WEAK. THIS IS CAUSING LITTLE TO NO BLOOD FLOW INTO THE TUBE AND PREVENTING US FROM COLLECTING THIS SAMPLE TYPE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8663069 ↗