Device product
MicroScan WalkAway-96 plus Instrument
Z-1371-2021
Product summary
- Event
- Event 87486
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 systems
- Official record key
device-enforcement:Z-1371-2021
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: B1018-284 UDI Code: 15099590658687 Serial Numbers: 39610001 39610002 39610003 39610004 39610005 39610006 39610007 39610008 39610009 39610010 39610011 39610012
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