Cytocell Ltd. Recall 92586
Description: RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Cytocell Ltd. Recall 92586 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2210-2023 |
| Event ID | 92586 |
| Event Description | RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, FL, OH, & SC. |
| Quantity | 61 units |
| Recall Reason | DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. |
| Device Classification | 20230726 |
| Device Code Info | Catalog No. LPS509-A; UDI-DI: 05055844900516; Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850. |
| Center Classification Date | 20230720 |
| Recall Initiation Date | 20230524 |
| Recalling Firm | Cytocell Ltd. |
| Initial Notification | Letter |
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