Cytocell DNA Diagnostic Probe Recalled for Unexpected Chromosomal Signals
Cytocell Ltd. is recalling a DNA diagnostic probe that may produce unexpected signals at additional chromosomal locations during testing. The affected probe is an in vitro diagnostic reagent used in laboratory cytogenetic analysis.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II diagnostic device recall with no reported illnesses or injuries. The hazard is analytical inaccuracy—the probe produces unexpected signals that could result in misdiagnosis—which represents a risk of harm to patients through incorrect diagnostic results, but injury has not yet been reported.
Plain-English summary
Cytocell Ltd. is recalling 23 units of the Cytocell LPH019-A E2A (TCF3) Breakapart Probe—an in vitro diagnostic reagent (ASR) used in laboratory testing. The product is designed to produce signals at chromosome location 19p13.3.
The probe has been found to produce unexpected locus-specific signals at an additional chromosomal location (9q34). This may result in false positive signals during testing that could lead to diagnostic errors.
The affected lots—073004 and 072518 (probe lot 200918-006)—were distributed nationwide to laboratories in California, Illinois, Kentucky, New York, Ohio, Texas, Utah, and Virginia. Laboratories using this product should discontinue use of the affected lots and contact the manufacturer for additional information.
The recalled product
- Product
- Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
- Manufacturer
- Cytocell Ltd.
- Hazard
- Affected units
- 23
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 (1)
- Lots 073004 and 072518 (Probe lot 200918-006).
Distribution
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