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Recall Observatory FDA recall evidence

Device product

Alinity m HBV Application Specification File (US and CE)

Z-0883-2022

March 04, 2022

Class II

Product summary

Firm
Abbott Molecular, Inc.
Event
Event 89757
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0883-2022

Official wording

Reason: There is a potential for misquantitation high results of negative samples.

Code information: List Numbers: 1) 08N47-03A (US); Version 1.00 2) 08N47-01B (CE); Version 2.00 3) 08N47-01C (CE); Version 3.00

Distribution pattern: US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for misquantitation high results of negative samples.