CLASS II Device recall · Reported 26 Aug 2020 · FDA Enforcement Report
LPH533-A NUP98 Distal Probe Green recalled by Cytocell
Cytocell is recalling Cytocell LPH533-A NUP98 Distal Probe Green, distributed nationwide in the US. The recall was initiated on 17 Jul 2020 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-2829-2020
- FDA event ID
- 86084
- Recalling firm
- Cytocell, Cambridge, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2020
- FDA classified
- 20 Aug 2020
- Reported
- 26 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Jul 2020 | Recall initiated by company | |
| 20 Aug 2020 | Classified by FDA | +34 days |
| 26 Aug 2020 | 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
A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.
Product as listed by the FDA
Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the country of Canada.
Questions about this recall
Is LPH533-A NUP98 Distal Probe Green recalled?
Yes. Cytocell recalled LPH533-A NUP98 Distal Probe Green on 17 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-2829-2020.
Why was it recalled?
A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.
Which lots are affected?
Lot numbers: 069915, 070433, 069305, 069468
Where was it sold?
Worldwide distribution - US Nationwide distribution and the country of Canada.
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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