Recall Z-1099-2021 ยท MVU Reagents, Specific, Analyte
Cytocell Ltd.
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
| Date | Dec 22, 2020 |
| Status | Terminated |
| Reason | 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. |
| 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 294 |
| Quantity | 72 |
| Distribution | Domestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.