Cytocell Ltd. Recall 87090
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
Cytocell Ltd. Recall 87090 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1099-2021 |
| Event ID | 87090 |
| Event 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 |
| Product Type | Devices |
| Distribution | Domestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to Canada. |
| Quantity | 72 |
| Recall 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. |
| Device Classification | 20210217 |
| Device Code Info | Lots 072240, 071390, and 072693 |
| Center Classification Date | 20210208 |
| Recall Initiation Date | 20201222 |
| Recalling Firm | Cytocell Ltd. |
| Initial Notification | |
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