FDA Device recall Z-0200-2024
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900
- FDA Device
- Class II
- ongoing
- Published 2023-11-08
On 2023-11-08 the FDA classified a Class II recall of RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900 by Randox Laboratories, citing RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0200-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-06 |
| Published | 2023-11-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Reason
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
Identifiers
| code_info | GTIN: 05055273206104 Lot/Batch Number: (1) 7201-0747 7201-0423 7201-0417 7201-0353 7255-0198 7255-0172 7255-0171 7255-0…GTIN: 05055273206104 Lot/Batch Number: (1) 7201-0747 7201-0423 7201-0417 7201-0353 7255-0198 7255-0172 7255-0171 7255-0129 7201-1085 7201-1086 7201-1079 7201-1080 7201-0982 7201-0977 7201-0970 7201-0950 7201-0924 7201-0919 7201-0901 7201-0849 7201-0827 7201-0801 7201-0768 7201-0606 7201-0562 7201-0535 7201-0531 7201-0482 (2)¿¿¿¿¿¿¿¿¿¿¿¿¿ 7201-0776 7201-0367 7201-0343¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿ 7201-0348 ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0200-2024%22
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