FDAClass IIApril 14, 2021

MicroScan WalkAway-40 plus Instrument recall

MicroScan WalkAway-40 plus Instrument

Why was MicroScan WalkAway-40 plus Instrument recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
MicroScan WalkAway-40 plus Instrument
Recalling firm
Beckman Coulter Inc.
Quantity
16 systems
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.
Recall date
April 14, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls