Z-0928-2022 Class II Ongoing
FDA device recall Z-0928-2022 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: 2,395.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 20, 2022
- Initiation Date
- Feb 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,395
Product Description
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
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: 00630414220697; Lot Numbers: 211392 211438 211484 211522 211526
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0928-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026