Randox Laboratories Ltd. Recall 88098
Description: Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Randox Laboratories Ltd. Recall 88098 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2013-2021 |
| Event ID | 88098 |
| Event Description | Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R |
| Product Type | Devices |
| Distribution | US Nationwide Distribution and Puerto Rico. |
| Quantity | 50 kits |
| Recall Reason | An issue was identified where the software froze during processing of commands, which resulted in no results displayed. |
| Device Classification | 20210714 |
| Device Code Info | GTIN 05055273206104, Serial Numbers: 7201-0423 7201-0417 7201-0353 7201-0776 7201-0367 7201-0921 7201-0982 7201-0977 7201-0970 7201-0950 7201-0924 7201-0919 7201-0901 7201-0849 7201-0827 7201-0799 7201-0801 7201-0768 7201-0606 7201-0562 7201-0535 7201-0531 7201-0381 7201-0112 7201-0231 7201-0275 7201-0299 7201-0319 7201-0343 7201-0348 7201-0391 7201-0514 7201-0515 7201-0540 7201-0605 7201-0616 7201-0840 7201-0533 7201-0932 7201-0943 7201-0513 7201-0482 7201-0960 7201-0882 7201-0434 7201-0607 7201-0768 7201-0961 7201-0980 7201-0994 |
| Center Classification Date | 20210706 |
| Recall Initiation Date | 20210428 |
| Recalling Firm | Randox Laboratories Ltd. |
| Initial Notification | Letter |
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