ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

THE ISSUE WAS DETECTABLE TO THE USER AS THE QC WAS CONSISTENTLY LOW OUT OF RANGE. BASED ON THE PROVIDED INFORMATION, THE ROOT CAUSE WAS CONSISTENT WITH AN ONBOARD STABILITY ISSUE OF VITAMIN B12 II KITS ON THE COBAS PURE E402 ANALYTICAL UNIT. A QUALITY NOTIFICATION WAS PUBLISHED.

Additional Manufacturer Narrative

THE COBAS PURE E402 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE QC TRACE SHOWED CAL.E ALARM ON 11-JAN-2025 SUGGESTING A CALIBRATION ISSUE. THE QC FROM 03-FEB-2025 AND 04-FEB-2025 WAS CONSISTENTLY BORDERLINE OR OUT OF RANGE. NO QC DATA WAS PROVIDED FROM 05-FEB-2025. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ELECSYS VITAMIN B12 G2 (VITAMIN B12 II) ASSAY ON A COBAS PURE E402 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 350 PG/ML. REPEAT RESULT: 669 PG/ML. SAMPLE 2: INITIAL RESULT: 100 PG/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 237 PG/ML. SAMPLE 3 AND SAMPLE 4 WERE TESTED ON (B)(6)2025: SAMPLE 3: INITIAL RESULT: 214 PG/ML. REPEAT RESULT: 375 PG/ML. SAMPLE 4: INITIAL RESULT: 224 PG/ML. REPEAT RESULT: 419 PG/ML. THE CUSTOMER HAD CALIBRATION AND QC ISSUES PROMPTING THE REPEAT OF THE SAMPLES IN ANOTHER LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.