Lower risk Medical device recall · FDA · Published January 9, 2023

Siemens Atellica Folate Test Kits: Negative Bias Risk in Blood Tests

Siemens Healthcare recalls Atellica IM Folate 140 test kits due to negative bias when testing serum samples. Affected kits may give inaccurate folate results. No remedy specified in recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1149-2023Medical device Siemens Healthcare ›

Lower-risk recall

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

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Contact the company

Recalling firmSiemens Healthcare Diagnostics, Inc.333 Coney St · East Walpole, MA 02032-1516

✎ GovInfoNow plain-language explainer

Siemens Healthcare is recalling Atellica IM Folate 140 test kits because they can produce negative bias when used with whole blood calibration. This means test results for folate in serum samples might be too low, potentially leading to incorrect health assessments. Read more at govinfonow.com/recall/59036-siemens-atellica-folate-test-kits-negative-bias-risk-in-blood.

Source Summary by GovInfoNow · govinfonow.com/recall/59036-siemens-atellica-folate-test-kits-negative-bias-risk-in-blood · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1149-2023

Cite this page

“Siemens Atellica Folate Test Kits: Negative Bias Risk in Blood Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59036-siemens-atellica-folate-test-kits-negative-bias-risk-in-blood. Based on FDA recall #Z-1149-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1149-2023%22&limit=1).

The FDA announced on Jan. 9, 2023, that Siemens Healthcare Diagnostics, Inc. is recalling Atellica IM Folate 140 test kits due to a negative bias hazard. The agency issued the recall for the in vitro diagnostic device affecting approximately 13,843 kits distributed nationwide and internationally.

How to tell if you have it

Brand: Siemens Healthcare
Product: Atellica IM Folate 140 test kit
UPC: 00630414598963
Lot Numbers: 15308337, 27949339, 41143343, 41144343, 62969345 and higher
Units affected: 13,843 kits

The hazard

The recall cites a negative bias that occurred when whole blood calibration was used to test serum samples. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Recent brand recalls include the Aug. 17, 2026, Atellica CH RCRP Test recall for false high results and the July 13, 2026, Immulite 2000 Syphilis Screen Recall for false negative risk. Other recent recalls of similar products include the March 13, 2026, Magellan LeadCare II Blood Lead Test Kits recall and the Dec. 5, 2025, Meridian Bioscience Revogene C. difficile Test recall.

How to tell if you have this one

Check for Siemens Material Number (SMN) 10995572 or lot numbers 15308337, 27949339, 41143343, 41144343, 62969345 and higher. The kits are sold for in vitro diagnostic use in folate testing.

Brand
Siemens Healthcare
Product
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
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Recall number	Product, codes & lots	Quantity
Z-1149-2023	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; (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 Numbers: 15308337, 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.	13,843 kits
Z-1150-2023	Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573; UDI: (01)00630414598970(10)15307337(17)20230320; (01)00630414598970(10)27948339(17)20230529; (01)00630414598970(10)41142343(17)20230630; (01)00630414598970(10)62968345(17)20230726. Lot Numbers: 15307337, 27948339, 41142343, 62968345 and higher. All current and future lots of the ADVIA Centaur Folate assay until the Instructions for Use are updated	9,272 kits
Z-1151-2023	Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252; UDI: (01)00630414293653(10)16097337(17)20230320 (01)00630414293653(10) 44861343 (17)20230630 (01)00630414293653(10) 63869345 (17)20230726 Lot Numbers: 16097337, 44861343, 63869345 and higher. Affects all current and future lots of the Atellica IM Folate assay until the Instructions for Use are updated.	1,865 kits
Z-1152-2023	ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308; UDI: (01)00630414204192(10)16275336(17)20230320; (01)00630414204192(10)21333336(17)20230320; (01)00630414204192(10)22318336(17)20230320; (01)00630414204192(10)23066336(17)20230320; (01)00630414204192(10)27947338(17)20230529; (01)00630414204192(10)62967344(17)20230726. Lot Numbers: 16275336, 21333336, 22318336, 23066336, 27947338, 62967344 and higher. Affects all current and future lots of the ADVIA Centaur Folate assay until the Instructions for Use are updated	14,669 kits
Z-1153-2023	ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10325366; UDI: (01)00630414450940(10)16276336 (17)20230320; (01)00630414450940(10)21334336(17)20230320; (01)00630414450940(10)22079336(17)20230320; (01)00630414450940(10)27946338(17)20230529; (01)00630414450940(10)41225342(17)20230630; (01)00630414450940(10)62966344 (17)20230726; Lot Numbers: 16276336, 21334336, 22079336, 27946338, 41225342, 62966344 and higher. Affects all current and future lots of the ADVIA Centaur Folate assay assay until the Instructions for Use are updated.	7,884 kits
Z-1154-2023	ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10331250 Siemens Material Number (SMN): 10325366; UDI: (01)00630414454597(10) 16277336(17)20230320; (01)00630414454597(10) 23278336 (17)20230320; (01)00630414454597(10)25958336(17)20230320; (01)00630414454597(10)63092344(17)20230726. Lot Numbers: 16277336, 23278336, 25958336, 63092344 and higher. Affects all current and future lots of the Advia Centaur Folate assay until the Instructions for Use are updated.	124 kits

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Number
Look for lot numbers 15308337, 27949339, 41143343, 41144343, 62969345 or higher on the test kit packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide Foreign: Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Bulgaria¿¿¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Cura¿ao,¿St¿Eus Cyprus¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 51 days after the firm started it.

Jan 9, 2023Firm started the recall
Feb 21, 2023FDA classified it Class II
Mar 1, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/59036-siemens-atellica-folate-test-kits-negative-bias-risk-in-blood">Siemens Atellica Folate Test Kits: Negative Bias Risk in Blood Tests (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1149-2023 (January 9, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1149-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.