Cytocell Ltd. Recall 88294
Description: Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Cytocell Ltd. Recall 88294 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2323-2021 |
| Event ID | 88294 |
| Event Description | Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's) |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA. |
| Quantity | 23 units |
| Recall Reason | May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34 |
| Device Classification | 20210825 |
| Device Code Info | Lots 073004 and 072518 (Probe lot 200918-006). |
| Center Classification Date | 20210818 |
| Recall Initiation Date | 20210527 |
| Recalling Firm | Cytocell Ltd. |
| Initial Notification | |
| Similar To |