Z-0929-2022 Class II Ongoing
FDA device recall Z-0929-2022 was initiated by Siemens Healthcare Diagnostics, Inc. on Feb 9, 2022 and is designated Class II. Reason for recall: Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. The recall status is ongoing. Affected quantity: 6606.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 20, 2022
- Initiation Date
- Feb 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6606
Product Description
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Reason for Recall
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Distribution Pattern
Global Distribution. US Nationwide.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0929-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026