FDA Devices recall · Reported April 30, 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
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.
Abbott Molecular recalled The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific … - a low-severity action.
The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific … was recalled by Abbott Molecular in April 30, 2014. Reason: 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe,…. Check the official notice for the remedy. Verify recall #Z-1491-2014 with the FDA Devices before acting.
The recall
Abbott Molecular issued this low-severity FDA Devices recall-20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe,….
- Low
- severity level
- Class III
- classification
- April 30, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1491-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1491-2014 |
| Date reported | April 30, 2014 |
| Date initiated | March 28, 2013 |
| Recalling firm | Abbott Molecular |
| Firm location | Des Plaines, IL |
| Affected scope | 20 kits |
| Distribution | 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1491-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026