Stago D-dimer assay shows positive bias across entire analytical range

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 Sat

Manufacturer

Diagnostica Stago, Inc.

Category

Medical Device — Diagnostic assay

Hazard

• measurement-bias
• inaccurate-results
• diagnostic-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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