BD DIFCO¿ SALMONELLA O ANTISERUM FACTOR 7
Received Oct 24, 2025 · Event occurred Sep 30, 2025
Report 1025402-2025-00011 · MDR key 23383833
Device
Generic name
Antisera, All Groups, Salmonella Spp.
Manufacturer
Lee Laboratories, Inc.Catalog number
228161
Lot number
4270060
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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
INVESTIGATION SUMMARY: NO RETURN SAMPLES WERE RECEIVED TO INVESTIGATE THIS COMPLAINT. TO INVESTIGATE THE COMPLAINT ON CATALOG 228161, LOT 4270060, ACCORDING TO THE PRODUCTS INSTRUCTIONS FOR USE, USING AVAILABLE CULTURE REPRESENTING SALMONELLA O ANTISERUM FACTOR 7 GROUP C1. FOR THE ANTISERUM TEST, A PORTION OF THE CULTURE WAS REMOVED FROM THE AGAR PLATE AND MIXED INTO ONE DROP OF ANTISERUM ON A SLIDE. IN ADDITION, THE 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: 4+ REACTIONS WERE OBSERVED AT UNDILUTED. NO REACTIVITY WAS OBSERVED WHEN THE CULTURE WAS TESTED IN SALINE. BASED ON THE TESTING PERFORMED THE COMPLAINT WAS NOT CONFIRMED. TO FURTHER INVESTIGATE THE BATCH HISTORY RECORD OF THE PRODUCT LOT WAS REVIEWED. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES, AND ALL RELEASE TESTING WAS SATISFACTORY. COMPLAINT TRENDS WERE ALSO REVIEWED COVERING A THREE-YEAR PERIOD. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED ON THE LOT NUMBER IN THE PERIOD REVIEWED.
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.
Description of Event or Problem
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.