MicroScan WalkAway-96 plus Instrument recall
MicroScan WalkAway-96 plus Instrument
Why was MicroScan WalkAway-96 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: B1018-284 UDI Code: 15099590658687 Serial Numbers: 39610001 39610002 39610003 39610004 39610005 39610006 39610007 39610008 39610009 39610010 39610011 39610012
- Product
- MicroScan WalkAway-96 plus Instrument
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 12 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)