Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Summary
The FDA issued a Class II for Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R by Randox Laboratories Ltd.. Reason: An issue was identified where the software froze during processing of commands, which resulted in no results displayed..
Details
Source
Device Recall
External ID
Z-2013-2021
Action Date
2021-07-14
Status
Terminated
Category
device
Product Description
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Lot/Code Info: GTIN 05055273206104, Serial Numbers: 7201-0423 7201-0417 7201-0353 7201-0776 7201-0367 7201-0921 7201-0982 7201-0977 7201-0970 7201-0950 7201-0924 7201-0919 7201-0901 7201-0849 7201-0827 7201-0799 7201-0801 7201-0768 7201-0606 7201-0562 7201-0535 7201-0531 7201-0381 7201-0112 7201-0231 7201-0275 7201-0299 7201-0319 7201-0343 7201-0348 7201-0391 7201-0514 7201-0515 7201-0540 7201-0605 7201-0616 7201-0840 7201-0533 7201-0932 7201-0943 7201-0513 7201-0482 7201-0960 7201-0882 7201-0434 7201-0607 7201-0768 7201-0961 7201-0980 7201-0994
Quantity Affected: 50 kits
Reason for Recall
An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
Distribution
US Nationwide Distribution and Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-28
Company
Crumlin (North)
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Randox Laboratories Ltd. has 39 FDA actions in our database, including 37 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Randox Laboratories Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Randox Laboratories Ltd. have FDA actions?
Randox Laboratories Ltd. has 39 FDA actions in our database, including 37 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2013-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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