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Recall Observatory FDA recall evidence

Device product

MicroScan WalkAway-96 plus Instrument

Z-1371-2021

September 04, 2019

Class II

Product summary

Firm
Beckman Coulter Inc.
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

    reason.manufacturing_process_control · v1.0.0

    Quality Control (QC) failure