Z-2467-2020 Class II Terminated
FDA device recall Z-2467-2020 was initiated by Radiometer Medical ApS on May 11, 2020 and is designated Class II. 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… The recall status is terminated (terminated February 24, 2023). Affected quantity: 9373 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2020
- Initiation Date
- May 11, 2020
- Termination Date
- February 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9373 units
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AK, 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, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of CA.
Code Information
All lots