CLASS II ONGOING Device recall · Reported 3 Nov 2021 · FDA Enforcement Report

Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) recalled

Siemens Healthcare Diagnostics is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151, distributed nationwide in the US. The recall was initiated on 20 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots impacted

Quantity recalled246 (US); 689 (OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0181-2022
FDA event ID: 88784
Recalling firm: Siemens Healthcare Diagnostics, Tarrytown, NY
Classification: Class II
Status: Ongoing
Recall initiated: 20 Sep 2021
FDA classified: 28 Oct 2021
Reported: 3 Nov 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

20 Sep 2021	Recall initiated by company
28 Oct 2021	Classified by FDA	+38 days
3 Nov 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

Product as listed by the FDA

Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151

Where it was distributed

Worldwide distribution - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All lots impacted

Where was it sold?

Worldwide distribution - US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 88784

Reported	Class	Recall	Company	Reason	Where
3 Nov 2021	CLASS II	Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN recalled	Siemens Healthcare Diagnostics	Other	Nationwide

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