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Recall Observatory FDA recall evidence

Device product

Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.

Z-0131-2015

April 07, 2014

Class II

Product summary

Firm
Abbott Laboratories, Inc
Event
Event 67987
Status
Terminated
Classification
Class II
Quantity
11916 units
Official record key
device-enforcement:Z-0131-2015

Official wording

Reason: Package inserts have incorrect SmartWash parameters for Triglyceride.

Code information: lots 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11.

Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Dominican Republic, Egypt, Estonia, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turks and Caicos, Turkey, Uganda, United Arab Emirates, United Kingdom, and Uruguay.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Package inserts have incorrect SmartWash parameters for Triglyceride.