IONIFY STEROIDS 1

Additional Manufacturer Narrative

THE ROOT CAUSE WAS DETERMINED TO BE DUE TO CONTAMINATION WITH THE ANALYTE FROM THE ENVIRONMENT. PER THE PRODUCT LABELING, "ESTRADIOL IS SHED NATURALLY IN SKIN PARTICLES, SALIVA, AND OTHER BODY FLUIDS AND CAN EASILY BE DISTRIBUTED VIA DUST OR AEROSOLS.19,20 AS A RESULT, LAB ENVIRONMENTS INCLUDING SAMPLES, CONSUMABLES, OR INSTRUMENTS MAY BE CONTAMINATED WITH ESTRADIOL. HIGH SENSITIVE ESTRADIOL ASSAYS MAY BE IMPACTED BY FALSELY ELEVATED ESTRADIOL ASSAY VALUES. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ESTRADIOL RESULTS WITH THE IONIFY STEROIDS 1 ASSAY FOR SEVERAL PATIENT SAMPLES TESTED ON THE COBAS I 601 INSTRUMENT. SAMPLE 1: THE INITIAL RESULT WAS 1.50 PG/ML (ACCOMPANIED BY A DATA FLAG). ON (B)(6) 2026, THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 1.50 PG/ML (ACCOMPANIED BY A DATA FLAG) AND 13.8 PG/ML. SAMPLE 2: THE INITIAL RESULT WAS 80.4 PG/ML (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 1.50 PG/ML (ACCOMPANIED BY A DATA FLAG) AND 2.42 PG/ML.