Device product

Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637

Z-0930-2022

February 09, 2022

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc.
Event: Event 89740
Status: Ongoing
Classification: Class II
Quantity: 199
Official record key: device-enforcement:Z-0930-2022

Official wording

Reason: Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

Code information: UDI: 00630414595580; Lot Numbers: 211359 211451

Distribution pattern: Global Distribution. US Nationwide.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.