Cytocell Recalls Chromosome X Alpha-Satellite Probes Due to Cross-Reactivity
Cytocell Ltd. is recalling 89 Chromosome X Alpha-Satellite probes because users may observe additional signals at 9q34, contradicting the insert.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II. The hazard involves a discrepancy between observed signals and the device insert, which is a labeling/documentation issue rather than a direct physical injury or high-risk pathogen exposure.
Plain-English summary
Cytocell Ltd. is recalling 89 units of Chromosome X Alpha-Satellite in FITC Spectrum probes (Model MPA3481). The recall involves specific lots: RD20/253/16, RD21/043/01, and RD21/043/02. These products were distributed nationwide in Texas, Ohio, New York, Illinois, Connecticut, Alabama, Iowa, and Missouri.
The recall was initiated because users may observe additional locus-specific signals at 9q34. The device pack insert indicates that the probe has no known cross-reactivity to 9q34, meaning the observed signals contradict the provided documentation.
Users of these specific lots should stop using the probes and contact Cytocell Ltd. for further instructions.
The recalled product
- Product
- Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
- Manufacturer
- Cytocell Ltd.
- Affected units
- 89
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 (3)
- Lot: RD20/253/16
- RD21/043/01
- RD21/043/02
Distribution
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