FDA Device Recall Z-0010-2019: Radiometer America Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0010-2019.

Recall Res Number

Z-0010-2019

Recalling Firm / Manufacturer

Radiometer America Inc

FEI Number

3010420736

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2018-05-25

Date Posted

N/A

Date Terminated

2020-11-06

Product Code

JJE

Event Number

80718

Product Quantity

12,102

Product Description ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Reason for Recall 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

Action Details The firm, Radiometer America, Inc., notified customers via letter dated 05/25/2015. The letter provided the following: Reason for recall, Affect product description and codes, Risk for the patient, What customers must do, Countermeasure provided by Radiometer, contact information and Response Form. The customers were instructed to do the following: 1. Inform users of the ABL90 FLEX analyzer that the inlet is not to be repeatedly lifted and closed. If this does happen, the easiest way to reset the analyzer flow selector manually is to re-install the solution pack. Follow the procedure described in the IFU for installation of a solution pack. You may re-use the same solution pack. 2. We recommend that you review previous results, where cNa+ and cCl- results are off from the expected results with the values found in table 1. 3. Complete the recall response fax form (last page of this customer advisory letter) and submit to your Radiometer representative via Fax to:714 582 0806. If you have any questions, please contact your Radiometer representative or Quality Assurance/ Regulatory Affairs Manager at 1-800-736-0600 opt.4.

Distribution Pattern US Distribution and Internationally to Canada.

Code Information / Serial Numbers ABL90 FLEX analyzers with software versions 3.3MR1 or below.

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Medical Device Recall: Z-0010-2019

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer