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Siemens Healthcare Diagnostics, Inc. Recall 90153

Description: Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001

Siemens Healthcare Diagnostics, Inc. Recall 90153 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1252-2022
Event ID90153
Event DescriptionAtellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
Product TypeDevices
DistributionWorldwide 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.
Quantity1,566
Recall ReasonLots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
Device Classification20220615
Device Code InfoUDI: 00630414007960 All lots
Center Classification Date20220609
Recall Initiation Date20220413
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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