Recall Z-2059-2018— Randox Laboratories
Class II · Terminated
Class II FDA medical device recall by Randox Laboratories, initiated 2018-05-04, terminated 2020-06-16. It names one FDA 510(k) clearance: K052914. 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..
- Recalling firm
- Randox Laboratories
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-04
- Terminated
- 2020-06-16
- Firm location
- Kearneysville, WV, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.