CLASS III Device recall · Reported 24 Sep 2014 · FDA Enforcement Report

Stago IVD, Liquid Anti-Xa recalled by Diagnostica Stago

Diagnostica Stago is recalling Stago IVD, Liquid Anti-Xa, distributed nationwide in the US. The recall was initiated on 18 Jul 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codes510(k) #K111822, Lot #112366, Part # REF 00311US

Quantity recalled514 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2650-2014
FDA event ID: 69070
Recalling firm: Diagnostica Stago, Parsippany, NJ
Classification: Class III
Status: Terminated
Recall initiated: 18 Jul 2014
FDA classified: 16 Sep 2014
Reported: 24 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

18 Jul 2014	Recall initiated by company
16 Sep 2014	Classified by FDA	+60 days
24 Sep 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

Distributed USA (nationwide) and the country of Canada.

Nationwide

Questions about this recall

Why was it recalled?

Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.

Which lots are affected?

510(k) #K111822, Lot #112366, Part # REF 00311US

Where was it sold?

Distributed USA (nationwide) and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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