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Siemens Healthcare Diagnostics, Inc. Recall: Atellica IM 1300 Analyzer - automated, immuno

Siemens Healthcare Diagnostics, Inc. Recall: Atellica IM 1300 Analyzer - automated, immuno is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Siemens Healthcare Diagnostics, Inc.; Product: Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic

Recalling firmSiemens Healthcare Diagnostics, Inc.
ProductAtellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
Reason for recallLots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
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,
Recall initiated20220413
Recall numberZ-1252-2022
Categorydevice
StateNY
CountryUnited States

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