Siemens Dimension Vista Thyroxine Assay Recalled for Drug Interference
Siemens is recalling Dimension Vista Thyroxine assays because sulfasalazine and sulfapyridine may cause inaccurate results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a theoretical risk of inaccurate test results due to drug interference, with no reported injuries or illnesses.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista Thyroxine (T4) assay (Product Number: K6065/10445101). The recall involves 19,991 units distributed in all 50 U.S. states, the District of Columbia, Guam, Puerto Rico, and 108 foreign countries.
The recall was initiated 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 for the Thyroxine (T4) assay.
Healthcare providers and laboratories should stop using the affected products and contact Siemens Healthcare Diagnostics for further instructions. Consumers should consult their healthcare providers regarding any recent test results that may have been affected by this issue.
The recalled product
- Product
- Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 19,991
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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