Agency classClass IIOur severity:High FDA (Devices)·Z-1152-2023·Announced 2023-03-01

Diagnostic folate test kits recalled for negative measurement bias

Siemens ADVIA Centaur Folate 100 test kits are recalled due to negative bias when whole blood calibration is used to test serum samples. The affected kits may produce falsely low folate results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for diagnostic test with documented measurement bias that could result in missed or under-diagnosed folate deficiency. Meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no illnesses have been reported despite the potential for patient harm through diagnostic error.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Folate 100 test kits (Siemens Material Number 10310308), used to measure folate levels in human serum and red blood cells. Approximately 14,669 kits have been distributed nationwide and internationally.

The recall was triggered by negative bias that occurs when whole blood calibration methods (such as Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) are used to test serum samples. When the incorrect calibration is applied, the test produces falsely low folate values.

Affected lot numbers include 16275336, 21333336, 22318336, 23066336, 27947338, 62967344, and all higher lot numbers. The issue persists in both current and future lots until the manufacturer updates the Instructions for Use.

The recalled product

Product: 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
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — Diagnostic Test Kit
Hazard: measurement-error
diagnostic-bias
Affected units: 14,669

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

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

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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