Lower riskMedical device recall · FDA · Published May 24, 2023
Cytocell RET Distal Probe Recall: DNA Inversion Risk in Lab Testing
Cytocell recalls RET Distal Probes used in lab DNA testing due to accidental DNA inversion during manufacturing. Affected models have specific catalog and lot numbers.
“Cytocell RET Distal Probe Recall: DNA Inversion Risk in Lab Testing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58086-cytocell-ret-distal-probe-recall-dna-inversion-risk-in-lab. Based on FDA recall #Z-2210-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2210-2023%22&limit=1).
The FDA announced on May 24, 2023, that Cytocell Ltd. is recalling the RET Distal Probe due to inverted DNA manufacturing errors. The agency issued recall number Z-2210-2023 for the Class II device distributed nationwide.
How to tell if you have it
Brand: Cytocell
Product: RET Distal Probe
Catalog No.: LPS509-A
UDI-DI: 05055844900516
Lot Nos.: 076764, 080124, 082129, 082560, 083247, 083550, 083850
The hazard
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. The product is used in Fluorescence in situ hybridization (FISH) to detect and locate specific DNA sequences on a chromosome.
Context
GovInfoNow's records show Cytocell Ltd. has 12 other recalls on record since March 15, 2019. Recent brand recalls include the BCL11B Reagent Recall and BCL11B Proximal Probe Mislabeling Risk from October 27, 2022, and the 8 Square Template Slides Recall with an Incorrect Expiry Date Label from February 14, 2022. Other recent recalls of similar products include the Hologic ThinPrep CytoLyt Solution Recall (December 12, 2025), Changchun Wancheng Bio-Electron UTI Test Strips Recall (November 22, 2025), and Exploro Fertility Test Recall (November 22, 2025).
How to tell if you have this one
Check for catalog number LPS509-A and lot numbers 076764, 080124, 082129, 082560, 083247, 083550, or 083850. The product is used in laboratory settings for DNA testing.
Brand
Cytocell
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of CA, FL, OH, & SC.
Recall number
Product, codes & lots
Quantity
Z-2209-2023
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.; Catalog No. LPS508-A; UDI-DI: 05055844900509; Lot No. 076763, 077253, 080125, 080763, 082128, 083041, 083246, 083555.
60 units
Z-2210-2023
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.; Catalog No. LPS509-A; UDI-DI: 05055844900516; Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850.
61 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the catalog number (LPS509-A) and lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, FL, OH, & SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Ohio, South Carolina.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2210-2023 (May 24, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2210-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.