MalfunctionGRM
BD DIFCO¿ SALMONELLA O ANTISERUM GROUP C1 FACTORS 6, 7
Received May 29, 2026 · Event occurred Apr 17, 2026
Report 1025402-2026-00003 · MDR key 25336881
Device
Generic name
Antisera, All Groups, Salmonella Spp.
Manufacturer
Lee Laboratories, Inc.Catalog number
229491
Lot number
3173174
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE USING THE BD DIFCO¿ SALMONELLA O ANTISERUM GROUP C1 FACTORS 6, 7, A PATIENT SAMPLE WAS IDENTIFIED BY THE REFERENCE LABORATORY AS GROUP R POSITIVE RATHER THAN C1 POSITIVE. NO PATIENT IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 2.
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.