MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD DIFCO¿ SALMONELLA O ANTISERUM FACTOR 7; ANTISERA, ALL GROUPS, SALMONELLA SPP.

Catalog Number	228161
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	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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
It was reported while using the antisera, all groups, salmonella spp.An unspecified number of patient samples failed to agglutinate.No health impact or consequence reported.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D10.Device available for eval- yes.D10.Returned to manufacturer on: 08-oct-2025.H3.Device eval by manufacturer- yes.Investigation summary: to investigate the complaint on catalog 228161, lot 3124670, a retained sample of the complaint lot and the returned sample were tested, according to the product instructions for use, with three available cultures representing salmonella o group c1.For each antiserum test, a portion of culture was removed from the agar plate and mixed into one drop of antiserum on a slide.In addition, each culture was tested in a drop of saline to check for roughness.Each slide was rotated for one minute before reading the reaction.Results were as follows: 2+ reactions were observed in both the retained and return vials, with two group c1 cultures tested.No reactivity was observed when the cultures were tested in saline.The complaint was confirmed based on the testing performed.The batch history record for the lot was reviewed and found satisfactory; no quality notifications were issued for the batch, and all release testing was satisfactory.Complaints for the product line were reviewed.There have been three other complaints received on the lot number in the three-year period reviewed.Bd will continue to monitor trends within this product line.No corrective action is needed at this time.
Event or Problem Description
It was reported while using the antisera, all groups, salmonella spp.An unspecified number of patient samples failed to agglutinate.No health impact or consequence reported.

• Brand Name: BD DIFCO¿ SALMONELLA O ANTISERUM FACTOR 7
• 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: 23383670
• Report Number: 1025402-2025-00010
• Device Sequence Number: 8790722
• Product Code: GRM
• UDI-Device Identifier: 00382902281610
• UDI-Public: (01)00382902281610(17)260918(10)3124670
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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 Expiration Date: 09/18/2026
• Device Catalogue Number: 228161
• Device Lot Number: 3124670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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