MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC BIOPLEX 2200 APLS IGM REAGENT PACK

Model Number	BIOPLEX 2200 APLS IGM REAGENT PACK
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bio-rad laboratories received a customer complaint regarding intermittent qc failure when running bioplex 2200 apls igm reagent packs, lot no.301538.Bio-rad laboratories determined that a small percentage of this reagent pack lot was packaged with the incorrect conjugate.There were no reported adverse event with this lot.However, the use of reagent packs containing the incorrect conjugate may lead to an increase of false positive and false negative results.
Event or Problem Description
Bio-rad laboratories received a customer complaint regarding intermittent qc failure when running bioplex 2200 apls igm reagent packs, lot no.301538.Bio-rad laboratories determined that a small percentage of this reagent pack lot was packaged with the incorrect conjugate.There were no reported adverse event with this lot.However, the use of reagent packs containing the incorrect conjugate may lead to an increase of false positive and false negative results.

• Brand Name: BIOPLEX 2200 APLS IGM REAGENT PACK
• Common Device Name: BIOPLEX 2200 APLS IGM
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC; 4000 alfred nobel dr; hercules CA 94547
• Manufacturer (Section G): BIO-RAD LABORATORIES, INC; 14620 ne north woodinville way; woodinville WA 98072
• Manufacturer Contact: ragu muniandy ; 5500 e second st; benicia, CA 94510 ; 5107415812
• MDR Report Key: 16507633
• Report Number: 1000135116-2023-00002
• Device Sequence Number: 6381888
• Product Code: MID
• UDI-Device Identifier: 00847865000666
• UDI-Public: 00847865000666
• Combination Product (Y/N): N
• PMA/510(K) Number: K130528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Inspection,Notification
• Type of Report: Initial
• Report Date (Section B): 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2024
• Device Model Number: BIOPLEX 2200 APLS IGM REAGENT PACK
• Device Catalogue Number: 665-2050
• Device Lot Number: 301538
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown