FDAClass IIOctober 10, 2018

ABL90 FLEX analyzers with software versions 3.3MR1 or recall

ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases…

Why was ABL90 FLEX analyzers with software versions 3.3MR1 or recalled?

The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes it again, thereby initiating a rinse ¿ Immediately after lifts the inlet and quickly closes it again

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?

ABL90 FLEX analyzers with software versions 3.3MR1 or below.

Product
ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases…
Recalling firm
Radiometer America Inc
Quantity
12,102
Distribution
US Distribution and Internationally to Canada.
Recall date
October 10, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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