Agency classClass IIOur severity:High FDA (Devices)·Z-1650-2018·Announced 2018-05-16

Siemens Dimension ALTI Assay Recalled for Drug Interference

Siemens is recalling Dimension ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.

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 where inaccurate diagnostic results could lead to improper medical decisions, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Alanine Aminotransferase (ALTI) assay, Product Number DF143/10475530. The recall involves 276,511 units distributed in all 50 U.S. states, the District of Columbia, Guam, Puerto Rico, and 108 foreign countries.

The recall was initiated because the assay may interfere with the drugs sulfasalazine and/or sulfapyridine. This interference can cause falsely elevated or falsely depressed results when measuring chemical levels in blood, urine, or cerebrospinal fluid.

Healthcare facilities and laboratories should stop using the affected assays and contact Siemens for further instructions. Patients who have had recent ALTI tests while taking sulfasalazine or sulfapyridine should consult their healthcare provider to discuss the potential impact on their results.

The recalled product

Product: Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: drug-interference
inaccurate-results
Affected units: 276,511

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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