Stago IVD Liquid Anti-Xa Recalled for Barcode Misreading
Diagnostica Stago is recalling 514 Liquid Anti-Xa kits due to customer complaints about barcode misreading on analyzers.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Diagnostica Stago, Inc. is recalling 514 kits of Stago IVD Liquid Anti-Xa (NDC 3607450003116). The recall is being conducted because the company received customer complaints regarding the misreading of the Reagent 1 (substrate) barcode on STA analyzers.
The affected product is intended for use with STA-R, STA Compact, and STA Satellite Analyzers to measure plasma levels of unfractionated and low molecular weight heparins. The specific lot number is 112366, and the part number is REF 00311US. The product was distributed nationwide in the United States and in Canada.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Users should contact Diagnostica Stago, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by…
- Manufacturer
- Diagnostica Stago, Inc.
- Hazard
- Affected units
- 514
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 (3)
- 510(k) #K111822
- Lot #112366
- Part # REF 00311US
Distribution
Distributed nationwide across the United States.
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