Device product
MicroScan WalkAway-40 plus Reconditioned Instrument
Z-1372-2021
Product summary
- Event
- Event 87486
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 systems
- Official record key
device-enforcement:Z-1372-2021
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: B1018-340R UDI Code: 15099590684112 Serial Numbers: 34020035 34020224 34030054 3407179 3407459 3407532
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