FDAFDA · Food and drugs·Recall number Z-1491-2014
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.
Published April 30, 2014 · Recall initiated: March 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Molecular
- Distributor
- Nationwide (CA, CO, CT, FL, HI, IL, IN, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI); Canada
- Lot
- List Number: 06J37-018; Lot Number: 440023
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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