MAUDE Adverse Event Report: BIO-RAD LABORATORIES,INC BIOPLEX 2200 ANTI-CCP REAGENT PACK

Model Number	BIOPLEX 2200 ANTI-CCP REAGENT PACK
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Bio-rad laboratories has received reports of discrepant results with lot no.301481 from four customers performing lot-to-lot validation against previous lots.Internal testing at bio-rad has demonstrated that lot no.301481 exhibits a reduction in specificity (potential for false positive results).There were no reported adverse event with this lot.However,false positive anti-ccp results could lead to incorrect diagnosis of rheumatoid arthritis and unnecessary medical treatment.
Additional Manufacturer Narrative
Bio-rad laboratories has received reports of discrepant results with lot no.301481 from four customers performing lot-to-lot validation against previous lots.Internal testing at bio-rad has demonstrated that lot no.301481 exhibits a reduction in specificity.The bias was observed on the low end of the assay range and none of the false positive results observed exceeded 9 u/ml (3x cut-off).This reduction in specificity may lead to an increase in the number of false positives and could lead to incorrect diagnosis of rheumatoid arthritis and unnecessary medical treatment.

• Brand Name: BIOPLEX 2200 ANTI-CCP REAGENT PACK
• Common Device Name: BIOPLEX 2200 ANTI-CCP
• Manufacturer (Section D): BIO-RAD LABORATORIES,INC; 4000 alfred nobel dr; hercules 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 94547 ; 5107415812
• MDR Report Key: 16422988
• Report Number: 1000135116-2023-00001
• Device Sequence Number: 5685251
• Product Code: NHX
• UDI-Device Identifier: 00847865000857
• UDI-Public: 00847865000857
• Combination Product (Y/N): N
• PMA/510(K) Number: K093954
• 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,Notification
• Type of Report: Initial

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: 02/29/2024
• Device Model Number: BIOPLEX 2200 ANTI-CCP REAGENT PACK
• Device Catalogue Number: 665-3250
• Device Lot Number: 301481
• 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: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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