FDA Device recall Z-2059-2018
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests by Randox Laboratories, citing abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2059-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-04 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Randox Laboratories |
| Distribution | PR, WV |
Product
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Reason
Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
Identifiers
| code_info | GTIN 05055273206104. All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2059-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.