FDA Medical Device Recalls (openFDA)
Radiometer America Inc: 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.
- Recall number
- Z-0010-2019
- Recalling firm
- Radiometer America Inc
- 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, 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.
- Status
- Terminated
- Initiated
- 2018-05-25
- Posted
- not on file
- Terminated
- 2020-11-06
- Reason
- 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
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 12,102
- Distribution
- US Distribution and Internationally to Canada.
- Lot, serial or model codes
- ABL90 FLEX analyzers with software versions 3.3MR1 or below.
- 510(k) numbers
- ["K120197"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 3010420736
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28