Agency classClass IIOur severity:High FDA (Devices)·Z-2282-2020·Announced 2020-06-17

Siemens ADVIA Chemistry Enzymatic Creatinine Recalled for Acetaminophen Interference

Siemens is recalling ADVIA Chemistry Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test 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: The recall involves a risk-of-harm product (medical diagnostic reagent) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 1,006 units of ADVIA Chemistry Enzymatic Creatinine_2 reagents (Material Number 10335869, UDI Number 00630414526690). The affected lots are 53149, 53150, 53151, 53152, 53941, 53942, 53943, 53944, 54354, 54371, 54372, 54373, and 54374. These products were distributed worldwide and nationwide in the United States, including in numerous states and Puerto Rico.

The recall was initiated because the presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. This product is used for the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.

The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself, nor does it report any illnesses or injuries associated with the use of these products.

The recalled product

Product: 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.
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — Laboratory Reagent
Hazard: test-interference
Affected units: 1,006

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 (13)

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

Distribution

Distributed nationwide across the United States.

The notice also names 42 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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Same hazard · test interference