RET Distal Probe Recalled Due to Manufacturing Defect in DNA Sequences
FDA recalls RET Distal Probe due to manufacturing defect where DNA sequences used in production were inverted. The defect affects 61 units distributed in California, Florida, Ohio, and South Carolina and may impact diagnostic accuracy.
What this means for you
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: Manufacturing defect in a diagnostic device (inverted DNA) creates risk of inaccurate test results. FDA Class II recall with no reported illnesses, injuries, or deaths. Meets the rubric criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The FDA has recalled the RET Distal Probe manufactured by Cytocell Ltd. The RET Distal Probe is a laboratory diagnostic tool used in Fluorescence in situ hybridization (FISH), a technique that detects and locates specific DNA sequences on chromosomes.
During manufacturing, DNA sequences used to create two affected probe models were accidentally inverted. This manufacturing defect may result in the probes not functioning as intended, potentially affecting the accuracy of diagnostic test results.
The recall involves 61 units with the following lot numbers: 076764, 080124, 082129, 082560, 083247, 083550, 083850. These units were distributed in California, Florida, Ohio, and South Carolina.
Laboratories that received affected units should contact Cytocell Ltd. for replacement probes. The defect is specific to manufacturing of these particular lot numbers and does not affect the general safety of the FISH diagnostic technique.
The recalled product
- Product
- RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
- Manufacturer
- Cytocell Ltd.
- Hazard
- manufacturing-defect
- diagnostic-inaccuracy
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 (9)
- Catalog No. LPS509-A
- UDI-DI: 05055844900516
- Lot No. 076764
- 080124
- 082129
- 082560
- 083247
- 083550
- 083850.
Distribution
Distributed nationwide across the United States.
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