D-Dimer test reagents recalled over potential underestimation of measured levels
Diagnostica Stago is recalling 12,740 units of STA Liatest D-Di across two lots because of a potential risk of underestimating D-Dimer levels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: an underestimated result can misdirect clinical interpretation, and no injuries are reported.
Plain-English summary
STA Liatest D-Di, REF 00515, is being recalled.
There is a potential risk of underestimation of D-Dimer levels with the two listed lots.
The recall covers 12,740 units carrying UDI-DI 03607450005158, from lots 271382 and 271411, both expiring 30 September 2025. Distribution was worldwide, including nationwide in the United States and to Canada. The FDA has classified the action as Class II.
A D-Dimer result that reads lower than the true value could affect how a clinician interprets the test. Laboratories holding the affected lots should follow Diagnostica Stago's instructions.
The recalled product
- Product
- Product: STA Liatest D-Di; REF: 00515;
- Manufacturer
- Diagnostica Stago, Inc.
- Affected units
- 12,740
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 (5)
- REF: 00515
- UDI-DI: 03607450005158
- Lot numbers: 271382
- 271411
- Expiration 09/30/2025
Distribution
Distributed nationwide across the United States.
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