MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC BIOPLEX 2200; Instrumentation for clinical multiplex test systems

Model Number	BIOPLEX 2200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).The customer clarified that the liquid contacted only her face and did not reach the eyes.She performed immediate decontamination of face and eyes using the eyewash station.No symptoms or irritation were reported following the incident.According to the user manual, the internal waste overflow container collects overflow from the general-purpose waste and sheath fluid reservoirs, meaning the liquid likely consisted mainly of sheath and cleaning fluids from clean stations with a small possible amount of general-purpose waste containing trace patient sample residue.As stated in section 2.3.6.2 of the operation manual, the internal overflow container is a backup reservoir intended to capture overflow only under error conditions from the general-purpose waste or sheath fluid reservoirs.Under normal operation, it is not expected to receive any fluid, and if it does this may represent a serious error condition and the error message "13211 general purpose waste - unable to purge" instructs the operator to contact bio-rad technical support.Additionally, according to the bioplex 2200 operation manual section 11.8, the internal overflow container may be emptied and cleaned by the operator as part of on-demand maintenance and should be performed as described in the troubleshooting section 11.8.4 or after consultation with bio-rad technical support.The bioplex 2200 processes human serum and plasma samples for various serological assays, therefore, the general-purpose waste may contain trace residues of patient material together with diluted reagents and wash buffers, classifying it as biohazardous laboratory waste.While the likelihood of viable infectious particles in post-assay waste is very low due to dilution and exposure to protein-denaturing reagents, trace contamination by blood-borne pathogens cannot be fully excluded.Section 1.4.1 "biohazards" of the operation manual displays a biohazard warning, stating that handling and disposing of solid and liquid waste, including liquid waste containers, may expose the operator to biohazardous conditions and instructs users to protect themselves from potentially biohazardous materials with adherence to the described guidelines, including always wearing laboratory gloves, coats, and safety glasses with side shields or goggles, and to comply with any local guidelines specific to their laboratory and location.Additionally, section 11.8.4, describing the cleaning of the internal overflow container, likewise displays a biohazard warning, reinforcing that appropriate protective wear must be used during this maintenance procedure.
Event or Problem Description
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.

• Brand Name: BIOPLEX 2200
• Common Device Name: Instrumentation for clinical multiplex test systems
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC; 4000 alfred nobel dr; hercules CA 94547
• Manufacturer Contact: ragu muniandy ; 40000 alfred nobel dr; 5107413941
• MDR Report Key: 23351235
• Report Number: 2915274-2025-00001
• Device Sequence Number: 9066746
• Product Code: NSU
• UDI-Device Identifier: 00847865002813
• UDI-Public: 00847865002813
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK140112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BIOPLEX 2200
• Device Catalogue Number: 660-0000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown