CLASS II Device recall · Reported 17 Feb 2021 · FDA Enforcement Report
Aquarius LPH 511-A CRLF2 Distal Probe Green recalled by Cytocell
Cytocell is recalling Aquarius LPH 511-A CRLF2 Distal Probe Green, distributed in 7 states. The recall was initiated on 22 Dec 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-1099-2021
- FDA event ID
- 87090
- Recalling firm
- Cytocell, Cambridge, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Dec 2020
- FDA classified
- 8 Feb 2021
- Reported
- 17 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Dec 2020 | Recall initiated by company | |
| 8 Feb 2021 | Classified by FDA | +48 days |
| 17 Feb 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting laboratory developed test (LDT) that utilizes the LPH511-A CRLF2 Distal Probe Green.
Product as listed by the FDA
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene
Where it was distributed
Domestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to Canada.
CaliforniaIllinoisMichiganMinnesotaNew JerseyTexasWashington
Questions about this recall
Is Aquarius LPH 511-A CRLF2 Distal Probe Green recalled?
Yes. Cytocell recalled Aquarius LPH 511-A CRLF2 Distal Probe Green on 22 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-1099-2021.
Why was it recalled?
Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting laboratory developed test (LDT) that utilizes the LPH511-A CRLF2 Distal Probe Green.
Which lots are affected?
Lots 072240, 071390, and 072693
Where was it sold?
Domestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to 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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