Stago IVD, Liquid Anti-Xa, NDC 3607450003116 recallZ-2650-2014 · Diagnostica Stago, Inc. · initiated Jul 18, 2014
Class III Terminated All recalls posted in September 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diagnostica Stago, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
FDA root cause category: Under Investigation by firm
What the company is doing
Diagnostica Stago sent a "Quality Information" letter/Customer Acknowledgement form to its customers. The letter identified the product, problem, and actions to be taken by the customers. For additional information and further support contact the Diagnostica Stago Hotline at 800-725-0607.
Recall details
- Recall number
- Z-2650-2014
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Jul 18, 2014
- Posted by the FDA
- Sep 16, 2014
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 514 kits
- Product code
- KFF
- FDA submissions
- K111822
- Distribution
- Distributed USA (nationwide) and the country of Canada.
Product description
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 measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
Code information (models, lots, serial numbers)
510(k) #K111822, Lot #112366, Part # REF 00311US
Other devices under the same FDA submission
2 devices cleared under K111822 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- STA® - Liquid Anti-Xa 4 00311USDiagnostica Stago · ASSAY, HEPARIN1 recall0 reports
- STA® - Liquid Anti-Xa 8 00322USDiagnostica Stago · ASSAY, HEPARIN1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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