Beckman Coulter Inc. recalls MicroScan WalkAway-96 plus Instrument

Recall date

September 4, 2019

Source

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

Recall number

Z-1371-2021

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

U.S.: CO, FL, IL, IN, KY, ME, MI, MS, PA, Puerto Rico, TN, TX, UT, VA and WA O.U.S.: India, Indonesia, Italy, Japan, Philippines, Poland, Russia, South Korea, Taiwan and Yemen.

Why it was recalled

Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

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

What was recalled

MicroScan WalkAway-96 plus Instrument