Diagnostica Stago recalled 12,740 STA Liatest D-Di units distributed worldwide after a potential risk of underestimating D-Dimer levels. The two listed lots may produce falsely low results. Stop using the devices immediately and follow recall instructions from Diagnostica Stago or your healthcare provider.
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Diagnostica Stago, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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D-Dimer immunoassays are used in clinical laboratories to help assess thrombotic risk in patients. The STA Liatest D-Di kit is part of this testing family. The recall concerns two lots with potential underestimation risk.
If D-Dimer levels are underestimated, clinicians may misinterpret results, potentially delaying diagnosis and treatment of blood clots.
This recall is not described as part of a broader industry pattern.
Hospitals and labs using affected lots may need to retest patient samples if results were impacted. The issue could affect diagnostic decisions and patient safety.
FDA recall page referenced in the notice; manufacturer instructions also apply
Timelines for refunds or replacements are not specified in the notice; contact Diagnostica Stago for details
Keep the recall notice, verify lot numbers, retain all packaging and labeling, photograph lot/expiry codes, document testing impact and communications with the manufacturer
Brand: Diagnostica Stago Product: STA Liatest D-Di Reference: REF 00515 UDI-DI: 03607450005158 Lot numbers: 271382, 271411 Expiration: 2025-09-30 Quantity: 12,740 units Sold worldwide, including US nationwide and Canada Recall status: ACTIVE Recall date: 2025-09-12 Report date: 2025-10-22
No injuries or incidents have been reported.
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