Siemens Dimension EXL TSH Reagent Cartridge Recall for Rare Variant Detection
Siemens Healthcare Diagnostics is recalling Dimension EXL TSH reagent cartridges because they fail to detect a rare TSH variant found in a small patient cluster.
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 is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate diagnostic results) where specific injury or illness has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). This medical device is intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). The recall involves 33,506 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because a rare variant of TSH, identified in a small cluster of patients, is not detected by the device. This limitation may result in inaccurate test results for patients with this specific variant.
Healthcare facilities and consumers should stop using the affected reagent cartridges and contact Siemens Healthcare Diagnostics for instructions on return or replacement. The agency has classified this as a Class II recall.
The recalled product
- Product
- Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 33,506
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)
- Per recall strategy.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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