# FDA recall Z-1498-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-06-28.

## Product

Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative  determination of iron in human serum and (lithium heparin) plasma samples.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1498-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-28
- **Report date:** 2022-08-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1498-2022

## Citation

> AI Analytics. FDA recall Z-1498-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1498-2022. Source: US FDA. Licensed CC0.

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