Device product
MicroScan WalkAway-96 plus Reconditioned Instrument
Z-1373-2021
Product summary
- Event
- Event 87486
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 systems
- Official record key
device-enforcement:Z-1373-2021
Official wording
Reason: 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.
Code information: Catalog Number: B1018-396R UDI Code: 15099590684129 Serial Numbers: 3967245 3967417 3967493 3967544 3967634 3967734 3967914 3928224 3968442
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.
Derived failure modes
-
Manufacturing or process control
Quality Control (QC) failure