MicroScan WalkAway-96 plus Instrument
Check against the official notice below — it lists the full affected range.
Beckman Coulter Inc. is recalling 12 MicroScan WalkAway-96 plus Instruments due to a manufacturing defect involving a shortened 30mL reagent draw straw. This defect may prevent reagents from dispensing properly, which could result in organisms being misidentified or Quality Control tests failing.
The affected instruments were distributed in the United States (including Colorado, Florida, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, and Washington) and internationally in India, Indonesia, Italy, Japan, Philippines, Poland, Russia, South Korea, Taiwan, and Yemen. The affected units have Catalog Number B1018-284, UDI Code 15099590658687, and serial numbers ranging from 39610001 through 39610012. The recall source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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. Quantity: 12 systems Lot/code info: Catalog Number: B1018-284 UDI Code: 15099590658687 Serial Numbers: 39610001 39610002 39610003 39610004 39610005 39610006 39610007 39610008 39610009 39610010 39610011 39610012
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.