Agency classClass IIOur severity:High FDA (Devices)·Z-1652-2018·Announced 2018-05-16

Siemens Dimension Glucose Assay Recalled for Drug Interference

Siemens Healthcare Diagnostics is recalling Dimension Glucose assays because they may produce inaccurate results when used with certain drugs.

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 medical device that may produce inaccurate diagnostic results due to drug interference, posing a risk of harm to patients through incorrect clinical decisions, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Glucose (GLUC) assay (Product Number: DF40/10444973). The recall involves 80,466 units distributed in all 50 U.S. states, the District of Columbia, Guam, Puerto Rico, and 108 foreign countries.

The recall is being conducted because various assays used to measure chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine. This interference can cause falsely elevated or falsely depressed results, which may impact clinical decision-making.

Healthcare providers and laboratories should stop using the affected Dimension Glucose assays and contact Siemens Healthcare Diagnostics for further instructions on the recall and replacement options.

The recalled product

Product: Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: inaccurate-results
drug-interference
Affected units: 80,466

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 (1)

All lots

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 17 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 17 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · inaccurate results