Reported Mar 1, 2023 · Ongoing

Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum…

Siemens Healthcare Diagnostics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics, Inc. · 333 Coney St · East Walpole, MA · 02032-1516

Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells
Siemens Material Number (SMN)10995572

Lot codes and dates: (01)00630414598963(10)15308337(17)20230320 (01)00630414598963(10)27949339(17)20230529 (01)00630414598963(10)41143343(17)20230630 (01)00630414598963(10)41144343(17)20230630 (01)00630414598963(10)62969345(17)20230726
Lot Numbers15308337, 27949339, 41143343, 41144343, 62969345 and higher. Affects all current and future lots of the Atellica IM Folate assay until the Instructions for Use are updated
Amount recalled: 13,843 kits

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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192 in total.