Stago D-dimer assay shows positive bias across entire analytical range
Diagnostica Stago is recalling the STA Liatest D-Di kit after investigations confirmed a positive bias in D-dimer measurements throughout the entire analytical range.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a confirmed bias affects an assay used to exclude pulmonary embolism and deep vein thrombosis, and no injuries are stated.
Plain-English summary
Diagnostica Stago, Inc. is recalling the STA Liatest D-Di kit, REF 00515, an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma, used with a clinical pretest probability assessment to exclude pulmonary embolism and deep venous thrombosis in outpatients. About 34,000 units were distributed, 28,446 in the United States and 5,554 outside it, to Canada, Singapore, Guam, Japan, South Korea and Russia. The FDA has classified this recall as Class II.
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-dimer measurements throughout the entire analytical range.
Affected product covers twelve listed lot numbers beginning 273015.
Laboratories can identify affected kits by the REF and lot numbers above, and may contact Diagnostica Stago, Inc. for further information.
The recalled product
- Product
- Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA…
- Manufacturer
- Diagnostica Stago, Inc.
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 (20)
- Model/Catalog Number: REF 00515
- UDIs: (1) (01)03607450005158(11)240630(17)250930(10)273015(241)00515
- (2) (01)03607450005158(11)250325(17)260630(10)273127(241)00515
- (3)(01)03607450005158(11)250416(17)260731(10)273275(241)00515
- (4)(01)03607450005158(11)250527(17)260831(10)273567(241)00515
- (5)(01)03607450005158(11)250618(17)260930(10)273681(241)00515
- (6)(01)03607450005158(11)250716(17)261031(10)273808(241)00515
- (7)(01)03607450005158(11)250716(17)261231(10)273808(241)00515
- (10) (01)03607450005158(11)250429(17)260731(10)273606(241)00515
- (11) (01)03607450005158(11)250709(17)261031(10)273805(241)00515
- (12) (01)03607450005158(11)251007(17)270131(10)274219(241)00515
- Lot numbers: (1)273015
- (2)273127
- (3)273275
- (4)273567
- (5)273681
- (6)273808
- (7)273995
- (8)274108
- (9)273128
Distribution
Distributed nationwide across the United States.
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