medical Class II Updated 2020-07-01

Siemens Healthcare Diagnostics, Inc. recalls Atellica Solution IM1600 Analyzer, Siemens Material Number 1

Recalled Product

Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026


Hazard / Issue

Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.

Issued by

FDA

Affected States: DC
Lot/Code Info: Atellica Tube Top Sample Cups, 1 mL, SMN 11069061; Atellica Tube Top Sample Cups, 2 mL, SMN 11069062; Sarstedt 62.612, 15.3 x 92 False Bottom, 4 mL
View official government recall

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