ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. CALIBRATION AND QC WERE NOT PERFORMED AS RECOMMENDED IN THE PRODUCT LABELING FOR THE ASSAY. PER PRODUCT LABELING: CALIBRATION SHOULD BE PERFORMED AFTER 1 MONTH (28 DAYS) WHEN USING THE SAME REAGENT LOT, AFTER 7 DAYS (WHEN USING THE SAME REAGENT KIT ON THE ANALYZER), OR AS REQUIRED. THE MOST RECENT CALIBRATION OF THE ASSAY WAS APPROXIMATELY 5 MONTHS PRIOR TO THE DATE OF THE EVENT. PER PRODUCT LABELING: CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER REAGENT KIT, AND FOLLOWING EACH CALIBRATION. QC WAS NOT PERFORMED ON THE DATE OF THE EVENT. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.

Additional Manufacturer Narrative

THE COBAS E411 RACK SERIAL NUMBER WAS (B)(6). VARIOUS COMPONENTS OF THE DEVICE, SUCH AS THE SURFACE, WASH STATIONS, REAGENT PROBE, SAMPLE PROBE, AND SIPPERS WERE CLEANED. THE MIXER WAS CHECKED TO ENSURE NO AIR BUBBLES WERE FORMED DURING MIXING, THE LAST CALIBRATION FROM (B)(6) 2025 WAS REVIEWED, FOLLOWED BY A NEW CALIBRATION AND QC, WHICH WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS VITAMIN B12 II RESULT FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT WAS 50 PG/ML. THE REPEAT RESULT WAS 442.7 PG/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER CONSIDERS THE SECOND RESULT TO BE CORRECT.