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Recall Observatory FDA recall evidence

Device product

Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000

Z-1253-2022

April 13, 2022

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 90153
Status
Ongoing
Classification
Class II
Quantity
2,321
Official record key
device-enforcement:Z-1253-2022

Official wording

Reason: Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results

Code information: UDI: 00630414002026 All lots

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Albania, Argentina, Austria, Bahamas, Bangladesh, Belgium, Brazil, Chile, China, Columbia, Croatia, Czech¿Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Latvia, Malaysia, Mexico, Netherlands, Paraguay, Peru, Philippines, Portugal, Romania, Russian¿Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results