CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report

Neoplastine¿ Cl Plus @ recalled by Diagnostica Stago

Diagnostica Stago is recalling Neoplastine¿ Cl Plus @ (, distributed nationwide in the US. The recall was initiated on 25 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 115080 (Exp: 01-2018) Lot 251241 (Exp: 01-2018)

Quantity recalled1636 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-1066-2018
FDA event ID: 79292
Recalling firm: Diagnostica Stago, Parsippany, NJ
Classification: Class II
Status: Terminated
Recall initiated: 25 Oct 2017
FDA classified: 15 Mar 2018
Reported: 21 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

25 Oct 2017	Recall initiated by company
15 Mar 2018	Classified by FDA	+141 days
21 Mar 2018	Published in enforcement report	+6 days

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

Reason for recall

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).

Where it was distributed

Nationally

Nationwide

Questions about this recall

Why was it recalled?

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Which lots are affected?

Lot 115080 (Exp: 01-2018) Lot 251241 (Exp: 01-2018)

Where was it sold?

Nationally

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

Other products in this recall event

3 other products · FDA event 79292

This product is part of a recall event; the main page for the event is STA - Neoplastine¿ Cl Plus ¿ recalled by Diagnostica Stago.

Reported	Class	Recall	Company	Reason	Where
21 Mar 2018	CLASS II	STA - Neoplastine¿ Cl Plus ¿ recalled by Diagnostica Stago	Diagnostica Stago	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	Neoplastine¿ Cl Plus ¿ recalled by Diagnostica Stago	Diagnostica Stago	Device Malfunction	Nationwide
21 Mar 2018	CLASS II	STA - Neoplastine¿ Cl ¿ recalled by Diagnostica Stago	Diagnostica Stago	Device Malfunction	Nationwide

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