Food, drugs, devices › Cytocell Ltd.
Device recall: RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating
FDA enforcement event 92586 is a device recall by Cytocell Ltd. of Cambridge, N/A, initiated 24 May 2023 and classified Class II, with 2 product records.
FDA defines Class II as 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. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Cytocell Ltd. has 13 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cytocell Ltd., Cambridge, N/A, United Kingdom.
Reason for recall
"DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing."
Distribution
"US Nationwide distribution in the states of CA, FL, OH, & SC."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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. | 60 units | Class II | Ongoing | 26 Jul 2023 |
| 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. | 61 units | Class II | Ongoing | 26 Jul 2023 |
Context
Other enforcement events for Cytocell Ltd.
All 13 events for Cytocell Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of CA, FL, OH, & SC."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.