Cytocell Ltd. Recall 87621
Description: Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Cytocell Ltd. Recall 87621 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1493-2021 |
| Event ID | 87621 |
| Event Description | Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO. |
| Quantity | 89 probes |
| Recall Reason | Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34. |
| Device Classification | 20210505 |
| Device Code Info | Lot: RD20/253/16, RD21/043/01, RD21/043/02 |
| Center Classification Date | 20210426 |
| Recall Initiation Date | 20210319 |
| Recalling Firm | Cytocell Ltd. |
| Initial Notification | |
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