CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report

Asserachrom HPIA recalled by Diagnostica Stago

Diagnostica Stago is recalling Asserachrom HPIA, distributed nationwide in the US. The recall was initiated on 15 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesReference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.

Quantity recalled438 units

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-1084-2026
FDA event ID: 98163
Recalling firm: Diagnostica Stago, Parsippany, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 15 Dec 2025
FDA classified: 14 Jan 2026
Reported: 21 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

15 Dec 2025	Recall initiated by company
14 Jan 2026	Classified by FDA	+30 days
21 Jan 2026	Published in enforcement report	+7 days

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

Reason for recall

Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.

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

Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.

Where it was distributed

Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI, IA, MA, MI, NJ, NV, NY, OH, TN, WI and the countries of Belgium, Canada, Denmark, Algeria, Spain, Finland, France, Great Britain, Italy, Lebanon, Saudi Arabia, Uganda.

Nationwide Alabama California Florida Georgia Hawaii Iowa Massachusetts Michigan New Jersey Nevada New York Ohio Tennessee Wisconsin

Questions about this recall

Why was it recalled?

Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.

Which lots are affected?

Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.

Where was it sold?

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.

More recalls from Diagnostica Stago

All 27

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
25 Mar 2026Device	CLASS II	STA Liatest D-Di recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
11 Mar 2026Device	CLASS II	STA Liatest Free Protein recalled by Diagnostica Stago	Diagnostica Stago	Device Malfunction	Nationwide
22 Oct 2025Device	CLASS II	STA Liatest D-Di recalled by Diagnostica Stago	Diagnostica Stago	Other	Nationwide
3 Sep 2025Device	CLASS II	STA - Fibrinogen recalled by Diagnostica Stago	Diagnostica Stago	Other	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide