Recall Z-1491-2014— Abbott Molecular

Class III FDA medical device recall by Abbott Molecular, initiated 2013-03-28, terminated 2016-03-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe..

Recalling firm

Abbott Molecular

Classification

Class III

Status

Terminated

Initiated

2013-03-28

Terminated

2016-03-08

Firm location

Des Plaines, IL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.