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Terminated

RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.

FDA Recall Z-2059-2018 · Posted None

Recalling FirmRandox Laboratories
Recall StatusTerminated
Product CodeJJE
Date Initiated2018-05-04
Date Terminated2020-06-16
Product Quantity41 analyzers

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.

Firm Action

All customers will be contacted directly by email and will be followed up with once every 2 weeks over a period of 6 weeks. Customers are advised to update the software in all analyzers. For further questions, please call 1 (866)472-6369.

Root Cause

Under Investigation by firm

Distribution Pattern

US Distribution including Puerto Rico and the state of : West Virginia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052914RX IMOLARandox Laboratories, Ltd. · 2006-03-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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