CHOLESTEROL GEN.2
Received Jun 12, 2026 · Event occurred May 19, 2026
Report 1823260-2026-02328 · MDR key 25487340
Device
Generic name
Enzymatic Esterase--oxidase, Cholesterol
Manufacturer
Roche DiagnosticsCatalog number
03039773190
Lot number
92880701
Product problems
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS INTEGRA 400 PLUS W/O ISE SERIAL NUMBER IS (B)(6). A FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE PROBES. THE CUSTOMER HAS OBSERVED AN OIL-LIKE SUBSTANCE ON THE SURFACE OF THE SAMPLES, ALONGSIDE INSTANCES OF THE SEPARATOR GEL MELTING AND ADHERING TO THE TUBE WALLS. THE CUSTOMER STATED THAT THE TUBES ARE STORED CORRECTLY WITHIN THE LABORATORY. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE CHOLESTEROL GEN.2 RESULT FROM THE COBAS INTEGRA 400 PLUS W/O ISE FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 448 MG/DL, AND THE REPEAT RESULT WAS 251 MG/DL.