MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD DIFCO¿ SALMONELLA H ANTISERUM SINGLE FACTOR 5; ANTISERA, ALL GROUPS, SALMONELLA SPP.

Catalog Number	224751
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Report 1 of 2 it was reported while using bd difco¿ salmonella h antiserum single factor 5, there was a false positive agglutination reaction in two kits.No patient impact reported.
Event or Problem Description
Report 1 of 2 it was reported while using bd difco¿ salmonella h antiserum single factor 5, there was a false positive agglutination reaction in two kits.No patient impact reported.
Additional Manufacturer Narrative
Investigation summary - no returns were received to investigate this complaint.The investigation began with understanding the entry description provided to the customer intake representative.From the hazard described to customer service, the customer received a false positive reaction with monophasic strains of salmonella typimurium.To investigate the complaint on catalog 224751, lot 4011976 the retained sample of the complaint lot was tested according to the products instructions for use.The antiserum was rehydrated and tested with two heterologous test panels at the routine test dilution of 1:500.No cross reactions were observed with strains typhimurium factor i and rubislaw factor r at 1:500 dilution.Based on the testing performed, the complaint was not confirmed.To further investigate, the batch history record for the complaint lot was reviewed and found to be satisfactory.Previous complaints received on the product line were reviewed covering a three-year period.During the review period no other complaints were received, on the complaints catalog or lot number; bd will continue to monitor trends.No corrective action is needed at this time.

• Brand Name: BD DIFCO¿ SALMONELLA H ANTISERUM SINGLE FACTOR 5
• Common Device Name: ANTISERA, ALL GROUPS, SALMONELLA SPP.
• Manufacturer (Section D): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• Manufacturer (Section G): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22613771
• Report Number: 1025402-2025-00001
• Device Sequence Number: 13162730
• Product Code: GRM
• UDI-Device Identifier: 00382902247517
• UDI-Public: (01)00382902247517(11)240111(17)270125(10)4011976
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: Other
• Device Catalogue Number: 224751
• Device Lot Number: 4011976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown