Radiometer Medical ApS Akandevej 21 Bronshoj Denmark ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. Recall

Check Your Product

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

Reason for Recall

As stated by FDA

Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment.

Recommended Action

Per FDA guidance

The firm will send consignees Urgent Medical Device Recall Letter dated 5/11/2020 via email and FedEx 2nd day delivery with proof of delivery on 5/11/2020 informing them that Radiometer has become aware that the internal barcode reader, included in every ABL80 FLEX Series analyzers, may potentially misinterpret 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. The issue identified only relates to barcode types not using a check digit. A check digit 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. For barcodes without a check digit, the following factors may add to the risk of misinterpretation: " Poor paper quality " Poor printer quality " Improper handling of the barcode (e.g. the barcode is folded or exposed to liquid) Radiometer uses only barcode types with a check digit when producing barcode labels used for e.g. sampler identification. They request customers to take the following actions: Check if their institution is using barcode types without a check digit, including e.g. patient ID or accession number, to be read on the ABL80. 1. If you use barcode types without a check digit, Radiometer recommends to either: o Enable the check digit on the barcode type currently used, or o Change the type of barcode to one that includes a check digit, as this enables the barcode reader to validate the data read, and hence, to recognize 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 is able to identify if the barcode has been misinterpreted and consequently rejects such data. Hence, no short-term action is required. 3. If you do not use locally generated barcodes to be read by the ABL80, no short-term action is required.