Z-1373-2021 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
- 9 systems
Product Description
MicroScan WalkAway-96 plus Reconditioned 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: B1018-396R UDI Code: 15099590684129 Serial Numbers: 3967245 3967417 3967493 3967544 3967634 3967734 3967914 3928224 3968442