Siemens Syva Emit 2000 Sirolimus Assay Recalled for Interference
Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Sirolimus Assay because it may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.
What this means for you
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, posing a risk of harm through incorrect medical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 226 units of the Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401). The recall covers all lots of the product. The affected assays were 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. Inaccurate results may lead to incorrect medical decisions regarding patient care.
Healthcare providers and laboratories should stop using the affected product and contact Siemens Healthcare Diagnostics for further instructions. Consumers should consult their healthcare provider if they have had recent test results using this assay.
The recalled product
- Product
- Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 226
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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