Recall Z-1099-2021— Cytocell Ltd.
Class II · Terminated
Class II FDA medical device recall by Cytocell Ltd., initiated 2020-12-22, terminated 2022-06-07. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Cytocell Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-22
- Terminated
- 2022-06-07
- Firm location
- Cambridge, N/A, United Kingdom
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.