Device product

Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

Z-0928-2022

February 09, 2022

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc.
Event: Event 89740
Status: Ongoing
Classification: Class II
Quantity: 2,395
Official record key: device-enforcement:Z-0928-2022

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: 00630414220697; Lot Numbers: 211392 211438 211484 211522 211526

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.