MicroScan WalkAway-40 plus Instrument
Check against the official notice below — it lists the full affected range.
Beckman Coulter Inc. is recalling 16 MicroScan WalkAway-40 plus instruments that were manufactured with a shortened 30mL reagent draw straw. This defect may prevent reagents from dispensing properly, which could lead to incorrect organism identification or Quality Control failures in laboratory testing. The affected instruments have catalog number B1018-283, UDI code 1509959065866, and serial numbers ranging from 34010001 through 34010016.
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 corrective 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: 16 systems Lot/code info: Catalog Number: B1018-283 UDI Code: 1509959065866 Serial Numbers: 34010001 34010002 34010003 34010004 34010005 34010006 34010007 34010008 34010009 34010010 34010011 34010012 34010013 34010014 34010015 34010016
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.