Device product

Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536

Z-0929-2022

February 09, 2022

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc.
Event: Event 89740
Status: Ongoing
Classification: Class II
Quantity: 6606
Official record key: device-enforcement:Z-0929-2022

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: 00630414220505; Lot Numbers: 110027 110060 110065 110091 110113 110129 110137 110161 110170 110208 110224 110234 110235 110262 110265 110273 110286 110315 110330 110347 110360

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.