Z-2059-2018 Class II Terminated
FDA device recall Z-2059-2018 was initiated by Randox Laboratories on May 4, 2018 and is designated Class II. 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. The recall status is terminated (terminated Jun 16, 2020). Affected quantity: 41 analyzers.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 13, 2018
- Initiation Date
- May 4, 2018
- Termination Date
- Jun 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 analyzers
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.
Distribution Pattern
US Distribution including Puerto Rico and the state of : West Virginia.
Code Information
GTIN 05055273206104. All serial numbers.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2059-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026