Radiometer Medical ApS: ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

Recall number

Z-1760-2020

Recalling firm

Radiometer Medical ApS

Product

ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

Status

Terminated

Initiated

2020-02-03

Posted

not on file

Terminated

2022-09-20

Reason

The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.

Root cause

Software design

Action

On 2/3/2020, the firm provided affected consignees with a "Urgent: Medical Device Recall" letter via Email, and hard copy letter via FedEx 2nd day. In addition to providing the recall notification, consignees were asked to take the following actions: Check if your institution is using barcode types without a check digit, including e.g. patient ID or accession number, to be read on the ABL90. 1. If you use barcode types without a check digit, Radiometer recommends to either: - Enable the check digit on the barcode type currently used, or - Change type of barcode to one that includes a check digit, as this enables the barcode reader to validate the data read, and hence, to capture if the barcode has been misinterpreted and consequently to reject such data. 2. If you use barcode types with a check digit the barcode reader already validates the data read, and hence, captures if the barcode has been misinterpreted and consequently rejects such data. Hence, no action required. 3. If you do not use barcodes to be read by the ABL90, no action required. 4.Complete the Recall Response Form (last page of this letter) and submit to your Radiometer distributor. Solution provided by Radiometer Radiometer has released software version V3.4 MR2, which we will install on your analyzer, disregarding which barcode type is used, or no barcodes are used at all. The new software version scans the barcode three times (as opposed to once in previous versions). For barcode types without a check digit, this change may potentially reduce the risk of misinterpretation, if caused by the factors, which may add to the risk of misinterpretation, mentioned above.

Quantity

12,822 units

Distribution

Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Canada, Netherlands, China, Croatia, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, South Korea, United Kingdom, Poland, Australia, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.

Lot, serial or model codes

software versions below 3.4 MR2

510(k) numbers

["K092686"]

PMA numbers

not on file

Product code

CEM

Firm FEI

3002807968

Firm city

Bronshoj

Firm state

not on file

Firm country

Denmark

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

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