Z-1491-2014 Class III Terminated
FDA device recall Z-1491-2014 was initiated by Abbott Molecular on Mar 28, 2013 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated Mar 8, 2016). Affected quantity: 20 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 30, 2014
- Initiation Date
- Mar 28, 2013
- Termination Date
- Mar 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 kits
Product Description
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 for Recall
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.
Distribution Pattern
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
Code Information
List Number: 06J37-018; Lot Number: 440023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1491-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026