BD COR¿ MX
Received Mar 13, 2026 · Event occurred Feb 25, 2026
Report 1119779-2026-00401 · MDR key 24597677
Device
Generic name
Thermal Cycler Nucleic Acid Amplification Analyser Ivd, Laboratory
Manufacturer
Becton Dickinson & Co. (sparks)Catalog number
443989
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED AFTER USING BD COR MX INSTRUMENT, THERE WAS ONE FALSE POSITIVE RESULT ON PATIENT SAMPLE. THE INSTRUMENT REPORTED POSITIVE FOR CHLAMYDIA, BUT THE SAMPLE WAS RETESTED THE NEXT DAY WITH A NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Additional Manufacturer Narrative
D2B. MEDICAL DEVICE TYPE: MKZ, OUY, QEP. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: THE CUSTOMER REPORTED A DISCREPANT RESULT ON COR MX, WHERE A POSITIVE URINE SAMPLE WAS REPEATED THE NEXT DAY, TESTED AS NEGATIVE. SERVICE OBTAINED R-FILES FOR REVIEW. UPON ANALYSIS, THE DISCREPANT RESULT WAS CLOSE TO THE LIMIT OF DETECTION FOR CYCLE THRESHOLD SCORES. THIS INDICATES THAT THE SAMPLE HAD A LOW TARGET LOAD TOO CLOSE TO THE LIMIT OF DETECTION. THE SECOND RUN DID NOT SHOW ANY AMPLIFICATION. THE RESULT WAS HELD DURING REPROCESSING. NO RETURNED PART WAS AVAILABLE OR EXPECTED AS PART OF THE INVESTIGATION. THE REVIEW DID NOT INDICATE ANY INSTRUMENT ISSUE. THIS COMPLAINT IS UNCONFIRMED AND THE ROOT CAUSE IS UNKNOWN. DHR REVIEW IS NOT REQUIRED FOR THIS COMPLAINT AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND THE CONFIGURATION HAS CHANGED SINCE RELEASE FOR MANUFACTURING DUE TO SERVICE REPAIRS/PMS. SERVICE HISTORY REVIEW FOR THIS INSTRUMENT WAS COMPLETED AND REVEALED RELATED COMPLAINTS RELATED TO THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THE FAILURE MODE DESCRIBED IN THIS COMPLAINT. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE.
Description of Event or Problem
IT WAS REPORTED AFTER USING BD COR MX INSTRUMENT, THERE WAS ONE FALSE POSITIVE RESULT ON PATIENT SAMPLE. THE INSTRUMENT REPORTED POSITIVE FOR CHLAMYDIA, BUT THE SAMPLE WAS RETESTED THE NEXT DAY WITH A NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.