ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

THE EXPIRATION DATE OF THE REAGENT WAS NOT PROVIDED. THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE. THE INITIAL VITAMIN B12 RESULT WAS <0.1 UG/ML. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 0.35 UG/ML.

Additional Manufacturer Narrative

MEDWATCH FIELD D4 LOT NO AND D4 EXPIRATION DATE WERE UPDATED. DUE TO THE LIMITED INFORMATION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.