MALVERN PANALYTICAL LTD Recall 90835
Description: NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
MALVERN PANALYTICAL LTD Recall 90835 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-1761-2022 |
| Event ID | 90835 |
| Event Description | NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size). |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 111 units |
| Recall Reason | Product found to not comply to Class 1 Laser safety requirement. |
| Device Classification | 20221005 |
| Device Code Info | CDRH accession # 0510530-001 |
| Center Classification Date | 20220926 |
| Recall Initiation Date | 20220228 |
| Recalling Firm | MALVERN PANALYTICAL LTD |
| Initial Notification | Letter |
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