CLASS II ONGOING Device recall · Reported 26 Jul 2023 · FDA Enforcement Report
RET Proximal Probe recalled by Cytocell
Cytocell is recalling RET Proximal Probe, distributed nationwide in the US. The recall was initiated on 24 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2209-2023
- FDA event ID
- 92586
- Recalling firm
- Cytocell, Cambridge, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 May 2023
- FDA classified
- 20 Jul 2023
- Reported
- 26 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 May 2023 | Recall initiated by company | |
| 20 Jul 2023 | Classified by FDA | +57 days |
| 26 Jul 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Product as listed by the FDA
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Where it was distributed
US Nationwide distribution in the states of CA, FL, OH, & SC.
Questions about this recall
Is RET Proximal Probe recalled?
Yes. Cytocell recalled RET Proximal Probe on 24 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2209-2023.
Why was it recalled?
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Which lots are affected?
Catalog No. LPS508-A; UDI-DI: 05055844900509; Lot No. 076763, 077253, 080125, 080763, 082128, 083041, 083246, 083555.
Where was it sold?
US Nationwide distribution in the states of CA, FL, OH, & SC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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