CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report

Abbott Diagnostics Architect Hbsag Assay(100tst/bx) Bds Reagent recalled

Mckesson Medical-Surgical Inc. Corporate Office is recalling Abbott Diagnostics Architect Hbsag Assay(100tst/bx) Bds Reagent, distributed nationwide in the US. The recall was initiated on 24 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog No. 04P5325; GTIN: 380740007775; Order No. 46061983.

Quantity recalled400 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-1847-2025
FDA event ID: 96752
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Apr 2025
FDA classified: 27 May 2025
Reported: 4 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

24 Apr 2025	Recall initiated by company
27 May 2025	Classified by FDA	+33 days
4 Jun 2025	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

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

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

ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.

Where it was distributed

US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.

Nationwide Alabama Arkansas Illinois Kansas Montana North Carolina New Jersey Oregon South Carolina Tennessee West Virginia

Questions about this recall

Is Abbott Diagnostics Architect Hbsag Assay(100tst/bx) Bds Reagent recalled?

Yes. Mckesson Medical-Surgical Inc. Corporate Office recalled Abbott Diagnostics Architect Hbsag Assay(100tst/bx) Bds Reagent on 24 Apr 2025. The recall is Class II and its status is Ongoing. Recall number Z-1847-2025.

Why was it recalled?

Which lots are affected?

Catalog No. 04P5325; GTIN: 380740007775; Order No. 46061983.

Where was it sold?

US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.

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 21 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 Mckesson Medical-Surgical Inc. Corporate Office

All 276

Reported	Class	Recall	Company	Reason	Where
27 Aug 2025Device	CLASS II	Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived recalled	Mckesson Medical-Surgical Inc. Corporate Office	Other	Nationwide
30 Jul 2025Drug	CLASS II	Prolia (denosumab), injection, 60mg/mL, For Subcutaneous Use Only recalledProlia	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	FL, VA
30 Jul 2025Drug	CLASS II	Benlysta (belimumab) for injection, 400 mg/ vial recalledBenlysta	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	FL, VA
30 Jul 2025Drug	CLASS II	Evenity, (romosozumab -aqqg) injection, 105mg recalledEvenity	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	FL, VA
4 Jun 2025Device	CLASS II	Abbott Diagnostics Alinity I Anti-ccps Reagent recalled	Mckesson Medical-Surgical Inc. Corporate Office	Device Malfunction	Nationwide

Other Test Kits & Diagnostics recalls

All 2,656

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein S recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Lead & Heavy Metals	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Lead & Heavy Metals	Nationwide