Recall Z-2467-2020— Radiometer Medical ApS
Class II · Terminated
Class II FDA medical device recall by Radiometer Medical ApS, initiated 2020-05-11, terminated 2023-02-24. It names one FDA 510(k) clearance: K051804. Product: 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.. Reason: 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..
- Recalling firm
- Radiometer Medical ApS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-11
- Terminated
- 2023-02-24
- Firm location
- Bronshoj, N/A, Denmark
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.