CLASS II Device recall · Reported 2 Dec 2015 · FDA Enforcement Report

Bd Cd64 Apc-r700 recalled by Becton, Dickinson and

Becton, Dickinson and Company, BD Biosciences is recalling Bd Cd64 Apc-r700, distributed in 9 states. The recall was initiated on 30 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry dte of 29 FEB 2016.

Quantity recalled23 vials

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-0334-2016
FDA event ID: 72548
Recalling firm: Becton, Dickinson and Company, BD Biosciences, San Jose, CA
Classification: Class II
Status: Terminated
Recall initiated: 30 Oct 2015
FDA classified: 24 Nov 2015
Reported: 2 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

30 Oct 2015	Recall initiated by company
24 Nov 2015	Classified by FDA	+25 days
2 Dec 2015	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

Three lots of CD64 (MD22) are contaminated with CD4 antibody.

Product as listed by the FDA

BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.

Where it was distributed

Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.

Florida Georgia Iowa Illinois North Dakota Pennsylvania Rhode Island Texas Washington

Questions about this recall

Why was it recalled?

Three lots of CD64 (MD22) are contaminated with CD4 antibody.

Which lots are affected?

Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry dte of 29 FEB 2016.

Where was it sold?

Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.

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 Becton, Dickinson and Company, BD Biosciences

All 35

Reported	Class	Recall	Company	Reason	Where
24 Jul 2024Device	CLASS II	BD Multitest 6-Color Tbnk Ce-ivd recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Biosciences	Other	34 states
17 Jan 2024Device	CLASS II	CD11b APC: ASR recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Biosciences	Other	Nationwide
9 Nov 2022Device	CLASS II	BD Trucount Tubes recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Biosciences	Other	43 states
9 Nov 2022Device	CLASS II	BD Trucount Tubes recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Biosciences	Other	43 states
9 Nov 2022Device	CLASS II	BD Multitest 6-Color TBNK with optional BD Trucount Tubes recalled	Becton, Dickinson and Company, BD Biosciences	Other	43 states

Other Test Kits & Diagnostics recalls

All 2,656

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein 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	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide