RX Imola recall: Software Issue
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Why was RX Imola recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 05055273206104. All serial numbers.
- Product
- RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
- Recalling firm
- Randox Laboratories
- Quantity
- 41 analyzers
- Distribution
- US Distribution including Puerto Rico and the state of : West Virginia.
- Recall date
- June 13, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)