Siemens Dimension Thyroxine Assay Recalled for Drug Interference
Siemens Healthcare Diagnostics is recalling Dimension Thyroxine assays because they may produce inaccurate results when used with certain drugs.
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, and the hazard involves potential diagnostic errors due to drug interference without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Thyroxine (T4) assay (Product Number: DF65/10444908). The recall involves 10,056 units of the product, which is used to measure chemical levels in blood, urine, or cerebrospinal fluid.
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 test results, potentially leading to incorrect medical interpretations.
The affected products were distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico, as well as in 108 foreign countries. All lots of the product are included in this recall. Healthcare facilities and laboratories should stop using the affected assays and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 10,056
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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