MicroScan WalkAway-40 plus Reconditioned Instrument
Check against the official notice below — it lists the full affected range.
Beckman Coulter Inc. is recalling six MicroScan WalkAway-40 plus reconditioned 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 organism misidentification or Quality Control failures. The affected instruments have catalog number B1018-340R and specific serial numbers (34020035, 34020224, 34030054, 3407179, 3407459, and 3407532), and were distributed to facilities in multiple U.S. states including Colorado, Florida, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Washington, as well as to Puerto Rico and several international locations.
The recall source does not specify a remedy or instructions 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: 6 systems Lot/code info: Catalog Number: B1018-340R UDI Code: 15099590684112 Serial Numbers: 34020035 34020224 34030054 3407179 3407459 3407532
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.