FDAJune 28, 2022device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
siemens healthcare diagnosticssiemenssiemens healthcare
UPCs
00630414596402
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.2026-04-22
- FDAepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;2026-04-02
- FDABiofire Spotfire Respiratory/Sore Throat Panel REF: 4234852026-04-01
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