Z-1370-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- September 4, 2019
- Termination Date
- January 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 systems
Product Description
MicroScan WalkAway-40 plus Instrument
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 Pattern
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.
Code Information
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