Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and

Recalled August 10, 2022 · FDA recall Z-1498-2022 · Siemens Healthcare Diagnostics

Hazard

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. · FDA Class II

Units

1614 units US ; 7,979 units OUS

Sold at

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.

Description

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.

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.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →