Device product
MicroScan WalkAway-40 plus Instrument
Z-1370-2021
Product summary
- Event
- Event 87486
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 systems
- Official record key
device-enforcement:Z-1370-2021
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: B1018-283 UDI Code: 1509959065866 Serial Numbers: 34010001 34010002 34010003 34010004 34010005 34010006 34010007 34010008 34010009 34010010 34010011 34010012 34010013 34010014 34010015 34010016
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