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.
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling Atellica CH Iron_2 devices used to measure iron levels in blood samples. The devices can cause falsely elevated results when a microalbumin test is performed immediately after an iron test, due to chemical carryover from the iron reagent. This issue affects 1,614 units in the United States and 7,979 units distributed internationally across numerous countries.
The recall applies to all lots of the Iron_2 assay, identified by the UDI code 00630414596402. The source document does not specify a remedy or recommended action for consumers who may have been affected by this device.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 1614 units US ; 7,979 units OUS Lot/code info: Unique Device Identification (UDI): 00630414596402 All lots
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.