MicroScan WalkAway-96 plus Reconditioned Instrument recall
MicroScan WalkAway-96 plus Reconditioned Instrument
Why was MicroScan WalkAway-96 plus Reconditioned 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: B1018-396R UDI Code: 15099590684129 Serial Numbers: 3967245 3967417 3967493 3967544 3967634 3967734 3967914 3928224 3968442
- Product
- MicroScan WalkAway-96 plus Reconditioned Instrument
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 9 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)