MicroScan WalkAway-96 plus Reconditioned Instrument
Check against the official notice below — it lists the full affected range.
Beckman Coulter Inc. is recalling 9 reconditioned 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, potentially causing organism misidentification and Quality Control failures. The affected instruments have catalog number B1018-396R and specific serial numbers ranging from 3967245 to 3968442.
The recalled instruments were distributed in the United States (Colorado, Florida, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, and Washington) and internationally (India, Indonesia, Italy, Japan, Philippines, Poland, Russia, South Korea, Taiwan, and Yemen). The source document does not specify a remedy or what affected consumers should do.
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: 9 systems Lot/code info: Catalog Number: B1018-396R UDI Code: 15099590684129 Serial Numbers: 3967245 3967417 3967493 3967544 3967634 3967734 3967914 3928224 3968442
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.