BioPlex 2200 6600000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847865002813), received between Dec 13, 2017 and Oct 21, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED BEING SPRAYED IN THE FACE WITH LIQUID FROM THE BIOPLEX 2200 INTERNAL WASTE OVERFLOW CONTAINER AFTER MANUALLY EMPTYING IT DURING ERROR 13211 (GENERAL PURPOSE WASTE - UNABLE TO PURGE). CUSTOMER HAS FLUSHED HER FACE AND EYES USING THE EYEWASH.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23351235 ↗
• MalfunctionNov 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE BIOPLEX IS CONNECTED TO A INPECO LABORATORY AUTOMATION SYSTEM (TLA). A SAMPLE WAS ADDED TO THE QUEUE FOR SAMPLING ON BIOPLEX AND AN ERROR OCCURRED. 2 SAMPLES THAT WERE BEHIND THE FIRST SAMPLE WERE NOT MOVED TO THE GATING AREA OF THE BIOPLEX, BUT BIOPLEX SHOWED SAMPLES ARE IN PROCESS. THE INCIDENT WAS DETECTED BY THE TESTING LABORATORY AND RESULTS WERE NOT REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15853697 ↗
• MalfunctionOct 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE BIOPLEX IS CONNECTED TO A INPECO LABORATORY AUTOMATION SYSTEM (TLA). DUE TO AN ERROR AT THE ASPIRATION POSITION OF THE TLA, A SAMPLE TUBE BECAME STUCK IN THE TRACK LINE AT THE BIOPLEX GATING AREA. THE BIOPLEX PIPETTED FROM THE TUBE SEVERAL TIMES AND MISASSIGNED THE SAMPLE TO SUBSEQUENT ACCESSION NUMBERS. THE INCIDENT WAS DETECTED BY THE TESTING LABORATORY AND RESULTS WERE NOT REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629585 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED A CALL ON (B)(6) 2017. TECHNICIAN REPORTED THAT WHILE HE WAS RUNNING A SAMPLE ON SEPTEMBER (B)(6) 2017, HE RECEIVED AN ERROR MESSAGE. THE SAMPLE RACK WAS STUCK. HE REMOVED THE FRONT COVER TO TRY TO GET THE RACK OUT WITH SOME FORCE AND THAT IS WHEN HE CUT HIS HAND. HE WAS RUNNING HIV TEST ON THE SYSTEM.

  Patient problems: Injury

  MAUDE report 7113356 ↗