D
Patient 1
BACKGROUND: THE CEP 8 SPECTRUMGREEN (SG) ASR PROBE KIT, 20UL (LIST 06J37-018) IS AN ANALYTE SPECIFIC REAGENT (ASR) CONTAINING A SINGLE VIAL OF CEP 8 SPECTRUM GREEN PROBE AND A CERTIFICATE OF ANALYSIS (COA). CHROMOSOME ENUMERATION PROBES (CEP) ARE CHROMOSOME-SPECIFIC FISH PROBES THAT HYBRIDIZE TO HIGHLY REPETITIVE HUMAN SATELLITE DNA SEQUENCES, USUALLY LOCATED NEAR CENTROMERES. CEP SIGNALS ENABLE THE IDENTIFICATION AND ENUMERATION OF HUMAN CHROMOSOMES IN INTERPHASE AND METAPHASE CELLS FROM FRESH AND ARCHIVED SAMPLES. THE LABEL FOR CEP 8 SG ASR PROBE KIT INDICATES IT IS AN ANALYTE SPECIFIC REAGENT, AND ANALYTICAL AND PERFORMANCE CHARACTERISTICS ARE NOT ESTABLISHED. ISSUE: A CUSTOMER RECEIVED ONE KIT OF CEP 8 SG ASR PROBE (LIST 06J37-018, LOT 440023), CONTAINING VYSIS CEP 4 (ALPHA SATELLITE) SG PROBE, 20UL, (PART 32-112004 LOT 438814) INSTEAD OF THE EXPECTED CEP 8 PROBE. THE CUSTOMER DID NOT USE THE KIT CONTAINING THE INCORRECT COMPONENT. ABBOTT MOLECULAR SENT A REPLACEMENT KIT TO THE CUSTOMER. IMPACT: PRODUCT FUNCTIONALITY IS IMPACTED BECAUSE USE OF CEP 4 (SG) WOULD NOT ACCURATELY ENUMERATE CHROMOSOME 8. THE CEP 8 SG PROBE AND THE CEP 4 SG PROBE BOTH PRODUCE GREEN SIGNALS NEAR THE CENTROMERE OF THEIR RESPECTIVE CHROMOSOMES. THE PRESENCE OF SPECTRUM GREEN SIGNALS NEAR THE CENTROMERE MAY LEAD THE TECHNICIAN TO CONCLUDE THE TEST WAS PERFORMED CORRECTLY. IF CEP 8 POSITIVE CONTROLS ARE NOT RUN WITH PATIENT SAMPLES, THEN THE POTENTIAL EXISTS TO GENERATE INCORRECT RESULTS. NOTE: THE CEP 4 PROBE VIALS WERE CORRECTLY LABELED TO IDENTIFY THE ACTUAL CONTENTS OF CEP 4 PROBE.