Radiometer Medical ApS: Medical Device Recall in 2020 - (Recall #: Z-2468-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

Product Classification:

Class II

Date Initiated: May 11, 2020

Date Posted: July 8, 2020

Recall Number: Z-2468-2020

Event ID: 85634

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.

Status: Terminated

Product Quantity: 1981

Code Information:

All lots

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.

Voluntary or Mandated:

Voluntary: Firm initiated