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Beckman Coulter Inc. Recall 87486

Description: MicroScan WalkAway-40 plus Instrument

Beckman Coulter Inc. Recall 87486 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1370-2021
Event ID87486
Event DescriptionMicroScan WalkAway-40 plus Instrument
Product TypeDevices
DistributionU.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.
Quantity16 systems
Recall ReasonInstruments 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.
Device Classification20210414
Device Code InfoCatalog Number: B1018-283 UDI Code: 1509959065866 Serial Numbers: 34010001 34010002 34010003 34010004 34010005 34010006 34010007 34010008 34010009 34010010 34010011 34010012 34010013 34010014 34010015 34010016
Center Classification Date20210407
Recall Initiation Date20190904
Recalling FirmBeckman Coulter Inc.
Initial Notification Letter
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