Agency classClass IIOur severity:High FDA (Devices)·Z-2134-2021·Announced 2021-08-04

Diagnostic Genetic Probe Recalled for Unexpected Chromosome Signals

Cytocell Ltd. is recalling CytoCell DiGeorge/VCFS genetic probes that may display unexpected chromosome signals, potentially causing misdiagnosis. Affected reagents were distributed to laboratories in multiple US states and Canada.

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 recall of a diagnostic medical device with an identified defect that could result in misdiagnosis. No illnesses or injuries have been reported. The score of 3 (High) reflects the risk-of-harm nature of a diagnostic tool with an identified issue, but without reported cases of actual patient harm.

Plain-English summary

Cytocell Ltd. is recalling the CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A, an analyte specific reagent used for in vitro genetic diagnostics. The product is distributed in the United States and Canada.

The device may show unexpected locus-specific signals in addition to those expected at chromosome 22q. Users may observe faint additional locus-specific signals at chromosome location 20p12/13. These unexpected signals could potentially be misinterpreted during diagnosis, leading to incorrect test results.

The recall affects laboratories and diagnostic facilities that received affected lots (071399 and 072985) in the states of California, Illinois, Missouri, New York, Pennsylvania, Texas, and Utah, as well as in Canada.

Laboratories currently using affected lots should stop use immediately and contact Cytocell Ltd. for instructions on returning or replacing the product. Healthcare providers should review any diagnostic results generated using affected lots to ensure accuracy.

The recalled product

Product: CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
Manufacturer: Cytocell Ltd.
Category: Medical Device — Diagnostic Reagent / Genetic Testing
Hazard: unexpected-signals
mis-diagnosis
Affected units: 50

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)

Lot Numbers: 071399 072985

Distribution

Distributed in 7 states:

Same manufacturer · Cytocell Ltd.

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Same hazard · unexpected signals