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.
FDA Recall Z-1491-2014 · Posted 2014-04-23
Advertisement
Recalling FirmAbbott Molecular
Recall StatusTerminated
Product CodeMVU
Date Initiated2013-03-28
Date Terminated2016-03-08
Product Quantity20 kits
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.
Firm Action
Customers were sent Field Correction Notices dated 3/28/13 instructing them to inspect their CEP 8 SpectrumGreen Probe kits for the presence of CEP4 probe vials. If any CEP4 vials are discovered, customers should contact their local Abbott Molecular Technical Support Represtative for coordination of reagent replacement with the correct CEP8 vial.
If customers have any specific questions they can contact Abbott Molecular at 1-800-553-7042, Option 2.
Root Cause
Packaging change control
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement