CLASS II Device recall · Reported 17 Jun 2020 · FDA Enforcement Report

Advia Chemistry Enzymatic Creatinine_2 recalled

Siemens Healthcare Diagnostics is recalling Advia Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, distributed nationwide in the US. The recall was initiated on 4 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s 53149, 53150, 53151, 53152, 53941, 53942, 53943, 53944, 54354, 54371, 54372, 54373, 54374

Quantity recalled1006

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-2282-2020
FDA event ID: 85602
Recalling firm: Siemens Healthcare Diagnostics, Newark, DE
Classification: Class II
Status: Terminated
Recall initiated: 4 May 2020
FDA classified: 5 Jun 2020
Reported: 17 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

4 May 2020	Recall initiated by company
5 Jun 2020	Classified by FDA	+32 days
17 Jun 2020	Published in enforcement report	+12 days

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

Reason for recall

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of North Carolina, California, Indiana, Florida, Ohio, Arizona, Massachusetts, New Jersey, New Hampshire, Illinois, Minnesota, Arkansas, New York, Delaware, Nevada, Kentucky, Washington DC, Montana, Missouri, Colorado, Maryland, Tennessee, Oregon, Virginia, Iowa, Wisconsin, Louisiana, Georgia, Pennsylvania, North Dakota, Mississippi, South Dakota, Washington, Nebraska, Texas, Alaska, Puerto Rico, Idaho, Oregon, Maine, Vermont, West Virginia, Kansas.

Nationwide Alaska Arkansas Arizona California Colorado District of Columbia Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Minnesota

Questions about this recall

Why was it recalled?

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

Which lots are affected?

Lot #s 53149, 53150, 53151, 53152, 53941, 53942, 53943, 53944, 54354, 54371, 54372, 54373, 54374

Where was it sold?

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

5 other products · FDA event 85602

This product is part of a recall event; the main page for the event is Advia Chemistry Fructosamine Reagent (Fruc) recalled.

Reported	Class	Recall	Company	Reason	Where
17 Jun 2020	CLASS II	Advia Chemistry Fructosamine Reagent (Fruc) recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
17 Jun 2020	CLASS II	Atellica CH Enzymatic Creatinine_2, Siemens Material Number recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
17 Jun 2020	CLASS II	Atellica CH Fructosamine Reagent (FRUC) recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
17 Jun 2020	CLASS II	Dimension Enzymatic Creatinine, Siemens Material Number recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
17 Jun 2020	CLASS II	Dimension Vista Enzymatic Creatinine recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide

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