Radiometer Medical ApS Akandevej 21 Bronshoj Denmark ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In vitro testing of samples of expired air for the parameters pO2 and pCO2 In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage: Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment

Recommended Action

Per FDA guidance

On 3/10/2020, a "Urgent: medical Device Recall" letter was sent via email and FedEx to affected consignees. In addition to informing the consignee about the recall issue, the recall notification asked customers to take the following action: 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 ABL800. 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 ABL800, no action required. 4. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer distributor. 5. If you have any questions, please contact us at 1-800-736-0600 option 1, Monday Friday 9am EST to 7pm EST. Solution provided by Radiometer Radiometer has released software version V6.19, 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.