Z-1498-2022 Class II Ongoing
FDA device recall Z-1498-2022 was initiated by Siemens Healthcare Diagnostics, Inc. on Jun 28, 2022 and is designated Class II. Reason for recall: Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test. The recall status is ongoing. Affected quantity: 1614 units US ; 7,979 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 10, 2022
- Initiation Date
- Jun 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1614 units US ; 7,979 units OUS
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AR, AU, AT, BS, BH, BD, BE, BR, BG, BF, CA, CL, CO, HR, CW, CZ, DK, EC, EG, EE, FI, FR, DE, GR, GP, HK, HU, IN, IR, IQ, IE, IL, IT, JP, JO, KE, KW, LV, LY, LT, MY, MX, MA, NL, NZ, NO, OM, CN, PK, PY, PE, PH, PL, PT, QA, KR, RO, RU, SA, RS, SG, SK, ZA, ES, SE, CH, TW, TH, TR, AE, UG, GB, UY, VA, VN.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1498-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026