Is ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. recalled?

Question

Accepted Answer

The firm received reports of occurrences where the  barcode reader misinterpreted 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.  This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.

Status: Voluntary: Firm initiated

Initial Firm Notification: Letter

Distribution: Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Canada, Netherlands, China, Croatia, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, South Korea, United Kingdom, Poland, Australia, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.

Affected Products

Additional Information

Were You Affected by This Recall?

Affected Products

Additional Information

Were You Affected by This Recall?