Siemens Tacrolimus Assay Recalled for Interference with Sulfasalazine and Sulfapyridine
Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Tacrolimus Assay because it 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 test results could lead to improper medical treatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397). The recall involves 10,067 units of the product, which is used to measure tacrolimus levels in blood, urine, or cerebrospinal fluid.
The recall is being issued because the assay may interfere with the drugs sulfasalazine and/or sulfapyridine. This interference can cause falsely elevated or falsely depressed results, potentially affecting clinical decision-making. The recall covers all lots of the product.
The product was distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico, as well as in 108 foreign countries. Healthcare providers and laboratories should stop using the affected product and contact Siemens Healthcare Diagnostics for further instructions on handling the recall.
The recalled product
- Product
- Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 10,067
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
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.
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