Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-1491-2014·Announced 2014-04-30

Abbott Molecular Recalls CEP 8 Probe Kits Containing Incorrect Probe

Abbott Molecular is recalling 20 kits of CEP 8 SG ASR Probe that contained the wrong probe. The kits contained Vysis CEP 4 probe instead of the expected CEP 8 probe.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a labeling/packaging error where the wrong probe was included, which is a moderate risk of diagnostic error but not a direct physical hazard.

Plain-English summary

Abbott Molecular is recalling 20 kits of the CEP 8 SpectrumGreen (SG) ASR Probe Kit, list number 06J37-018, lot number 440023. The recall was initiated because the kits contained Vysis CEP 4 (Alpha Satellite) SG Probe, part number 32-112004, lot number 438814, instead of the expected CEP 8 probe.

The affected kits were distributed nationwide in the United States and in Canada. The specific states listed for distribution include California, Colorado, Connecticut, Florida, Hawaii, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, and Wisconsin.

The CEP 8 SG ASR Probe Kit is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis. Chromosome enumeration probes are used to identify and enumerate human chromosomes in interphase and metaphase cells. Users should stop using the affected kits and contact Abbott Molecular for further instructions.

The recalled product

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…
Manufacturer: Abbott Molecular
Category: Medical Device — In Vitro Diagnostic
Hazard: mis-labeling
incorrect-product
Affected units: 20

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

List Number: 06J37-018
Lot Number: 440023

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Same manufacturer · Abbott Molecular

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