Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0929-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 9, 2022

Date Posted: April 20, 2022

Recall Number: Z-0929-2022

Event ID: 89740

Reason for Recall:

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

Status: Ongoing

Product Quantity: 6606

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.

Voluntary or Mandated:

Voluntary: Firm initiated