Beckman Coulter Inc. recalls The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog…

Recall date

December 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1077-2019

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

US: NJ, OH, NY, GA, FL, TN, WI, MI, MS, CA, NC, TX, PA, DC, IN, KY, IL, WA, MN, LA, ND, ID, WV, AK, AL, MA. OUS: Argentina, Australia, Bahrain, Canada, China, Croatia, Czech Republic, Egypt, Germany, Greece, India, Italy, Malaysia, Morocco, Netherlands, Nigeria, Poland, Portugal, Qatar, Saudi Arabi…

Why it was recalled

When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.