Z-1099-2021Class II

Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green...

Name: Z-1099-2021 Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green...
Creator: Cytocell Ltd.
Published: 2020-12-22
License: https://open.fda.gov/license/

Cytocell Limited / initiated 2020-12-22 / Terminated

FDA source

Cytocell Ltd. began a recall of 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... on 2020-12-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1099-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-22
Posted: 2021-02-08
Terminated: 2022-06-07
Recalling firm: Cytocell Limited
Product: 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
Product code: MVU Reagents, Specific, Analyte
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.
FDA root cause: Under Investigation by firm
Action: The firm began distributing recall notifications to customers on December 22, 2020. Customers were informed of the product issue. Customers were instructed to do the following: Immediately examine your inventory and quarantine all product subject to recall. The firm requests that you destroy the remaining inventory. The firm also suggests that laboratories review any results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of any additional locus specific signal at 11q13. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or [email protected].
Quantity in commerce: 72
Distribution: Domestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to Canada.
Product codes and lots: Lots 072240, 071390, and 072693

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1099-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1099-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-08

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)