BD MAX™ Enteric Parasite Panel 442960Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00382904429607), received between Aug 4, 2021 and Sep 3, 2026 — classified as 70 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (62 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 17, 2019Terminated

   The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

   Z-2329-2019 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589667 ↗
• MalfunctionMar 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE GIARDIA PATIENT RESULT WAS OBTAINED. SAMPLE WAS SENT TO A REFERENCE LAB FOR CONFIRMATION TESTING, AND WAS GIARDIA NEGATIVE USING AN UNSPECIFIED ASSAY. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498658 ↗
• MalfunctionMar 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE GIARDIA PATIENT RESULT WAS OBTAINED. SAMPLE WAS SENT TO A REFERENCE LAB FOR CONFIRMATION TESTING, AND WAS GIARDIA NEGATIVE USING AN UNSPECIFIED ASSAY. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498656 ↗
• MalfunctionFeb 24, 2026False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE CRYPTOSPORIDIUM PATIENT RESULT WAS OBTAINED. SAMPLE WAS SENT TO A REFERENCE LABORATORY AND WAS CRYPTOSPORIDIUM NEGATIVE. SAMPLE WAS ALSO TESTED WITH QUICKCHEK ASSAY AND WAS ALSO CRYPTOSPORIDIUM NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428688 ↗
• MalfunctionFeb 23, 2026False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE CRYPTOSPORIDIUM PATIENT RESULT WAS OBTAINED. SAMPLE WAS SENT TO A REFERENCE LABORATORY AND WAS CRYPTOSPORIDIUM NEGATIVE. SAMPLE WAS ALSO TESTED WITH QUICKCHEK ASSAY AND WAS ALSO CRYPTOSPORIDIUM NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415544 ↗
• MalfunctionFeb 23, 2026False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE CRYPTOSPORIDIUM PATIENT RESULT WAS OBTAINED. SAMPLE WAS SENT TO A REFERENCE LABORATORY AND WAS CRYPTOSPORIDIUM NEGATIVE. SAMPLE WAS ALSO TESTED WITH QUICKCHEK ASSAY AND WAS ALSO CRYPTOSPORIDIUM NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415543 ↗
• MalfunctionFeb 23, 2026False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE CRYPTOSPORIDIUM PATIENT RESULT WAS OBTAINED. SAMPLE WAS SENT TO A REFERENCE LABORATORY AND WAS CRYPTOSPORIDIUM NEGATIVE. SAMPLE WAS ALSO TESTED WITH QUICKCHEK ASSAY AND WAS ALSO CRYPTOSPORIDIUM NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415542 ↗
• MalfunctionFeb 23, 2026False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE CRYPTOSPORIDIUM PATIENT RESULT WAS OBTAINED. SAMPLE WAS SENT TO A REFERENCE LABORATORY AND WAS CRYPTOSPORIDIUM NEGATIVE. SAMPLE WAS ALSO TESTED WITH QUICKCHEK ASSAY AND WAS ALSO CRYPTOSPORIDIUM NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415541 ↗
• MalfunctionFeb 23, 2026False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE CRYPTOSPORIDIUM PATIENT RESULT WAS OBTAINED. SAMPLE WAS SENT TO A REFERENCE LABORATORY AND WAS CRYPTOSPORIDIUM NEGATIVE. SAMPLE WAS ALSO TESTED WITH QUICKCHEK ASSAY AND WAS ALSO CRYPTOSPORIDIUM NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415538 ↗
• MalfunctionFeb 23, 2026False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE CRYPTOSPORIDIUM PATIENT RESULT WAS OBTAINED. SAMPLE WAS SENT TO A REFERENCE LABORATORY AND WAS CRYPTOSPORIDIUM NEGATIVE. SAMPLE WAS ALSO TESTED WITH QUICKCHEK ASSAY AND WAS ALSO CRYPTOSPORIDIUM NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415537 ↗
• MalfunctionFeb 23, 2026False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE CRYPTOSPORIDIUM PATIENT RESULT WAS OBTAINED. SAMPLE WAS SENT TO A REFERENCE LABORATORY AND WAS CRYPTOSPORIDIUM NEGATIVE. SAMPLE WAS ALSO TESTED WITH QUICKCHEK ASSAY AND WAS ALSO CRYPTOSPORIDIUM NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415534 ↗
• MalfunctionFeb 23, 2026False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE CRYPTOSPORIDIUM PATIENT RESULT WAS OBTAINED. SAMPLE WAS SENT TO A REFERENCE LABORATORY AND WAS CRYPTOSPORIDIUM NEGATIVE. SAMPLE WAS ALSO TESTED WITH QUICKCHEK ASSAY AND WAS ALSO CRYPTOSPORIDIUM NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415525 ↗
• MalfunctionJan 6, 2026False Positive Result

  REPORT 3 OF 3: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE GIARDIA PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED WITH A NEW REAGENT KIT LOT AND WAS GIARDIA POSITIVE. TEST WAS THEN REPEATED WITH THE SAME REAGENT KIT LOT AND WAS GIARDIA NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979887 ↗
• MalfunctionJan 6, 2026False Positive Result

  REPORT 2 OF 3: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE GIARDIA PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED WITH A NEW REAGENT KIT LOT AND WAS GIARDIA POSITIVE. TEST WAS THEN REPEATED WITH THE SAME REAGENT KIT LOT AND WAS GIARDIA NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979866 ↗
• MalfunctionJan 6, 2026False Positive Result

  REPORT 1 OF 3: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE GIARDIA PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED WITH A NEW REAGENT KIT LOT AND WAS GIARDIA POSITIVE. TEST WAS THEN REPEATED WITH THE SAME REAGENT KIT LOT AND WAS GIARDIA NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979865 ↗
• MalfunctionDec 17, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A PATIENT SAMPLE TESTED DUAL POSITIVE FOR GIARDIA AND CRYPTOSPORIDIUM. SAMPLE WAS REPEATED ON MAX AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828871 ↗
• MalfunctionDec 17, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A PATIENT SAMPLE TESTED DUAL POSITIVE FOR GIARDIA AND CRYPTOSPORIDIUM. SAMPLE WAS REPEATED ON MAX AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828508 ↗
• MalfunctionDec 17, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A PATIENT SAMPLE TESTED DUAL POSITIVE FOR GIARDIA AND CRYPTOSPORIDIUM. SAMPLE WAS REPEATED ON MAX AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828497 ↗
• MalfunctionDec 17, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A PATIENT SAMPLE TESTED DUAL POSITIVE FOR GIARDIA AND CRYPTOSPORIDIUM. SAMPLE WAS REPEATED ON MAX AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828491 ↗
• MalfunctionDec 17, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A PATIENT SAMPLE TESTED DUAL POSITIVE FOR GIARDIA AND CRYPTOSPORIDIUM. SAMPLE WAS REPEATED ON MAX AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828490 ↗
• MalfunctionOct 21, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE CRYPTOSPORIDIUM PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON MAX AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350918 ↗
• MalfunctionSep 3, 2025False Positive Result; False Positive Result

  IT WAS REPORTED WHILE USING THE BD MAX¿ ENTERIC PARASITE PANEL, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951755 ↗
• MalfunctionSep 3, 2025False Positive Result; False Positive Result

  IT WAS REPORTED WHILE USING THE BD MAX¿ ENTERIC PARASITE PANEL, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951741 ↗
• MalfunctionSep 3, 2025False Positive Result; False Positive Result

  IT WAS REPORTED WHILE USING THE BD MAX¿ ENTERIC PARASITE PANEL, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951736 ↗
• MalfunctionApr 24, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC PARASITE PANEL, A GIARDIA LAMBLIA FALSE POSITIVE PATIENT RESULT WITH AN NOISY PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899820 ↗