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Terminated

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

FDA Recall Z-1099-2021 · Posted None

Recalling FirmCytocell Ltd.
Recall StatusTerminated
Product CodeMVU
Date Initiated2020-12-22
Date Terminated2022-06-07
Product Quantity72

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.

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].

Root Cause

Under Investigation by firm

Distribution Pattern

Domestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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