Reported Aug 28, 2019 · Terminated
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Radiometer America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Radiometer America Inc · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- ABL90 FLEX Analyzer REF 393090 UDI05700693930909
- Lot codes and dates
- All lots with the operating system versions - RXPE -UIM2743 v1.3XXXXXX or RXPE-UIM910 v1.3.XXXXXX
- Amount recalled
- 13,042 units
Where it was sold
Why it was recalled
Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
This product could cause temporary or reversible health problems — stop using it.
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