Cytocell NUP98 Distal Probe Green Recalled for False Positive Risk
Cytocell Ltd. is recalling NUP98 Distal Probe Green units due to a low risk of false positive results in laboratory testing.
What this means for you
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 source explicitly describes the risk as 'low risk' and the agency classification is Class II. This aligns with the rubric for moderate severity, representing a precautionary recall for a theoretical hazard without reported injuries.
Plain-English summary
Cytocell Ltd. is recalling 62 units of the Cytocell LPH533-A NUP98 Distal Probe Green. The recall involves specific lot numbers: 069915, 070433, 069305, and 069468. The product was distributed worldwide, including the United States and Canada.
The recall was initiated because of a low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes this probe. The probe is used in Fluorescence in situ hybridisation (FISH) to visualize DNA sequences upon chromosomes.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any specific adverse health events or injuries resulting from the use of the product.
The recalled product
- Product
- Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the vis
- Manufacturer
- Cytocell Ltd.
- Hazard
- Affected units
- 62
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 (4)
- Lot numbers: 069915
- 070433
- 069305
- 069468
Distribution
Distributed nationwide across the United States.
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