Device recall: BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for…

Class II FDA enforcement event 86655. Recall start date: 5 Oct 2020. Status in the FDA record: Terminated. Termination date: 11 Mar 2022.

Reason for recall, in the words of FDA

Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Becton, Dickinson and Company, BD Biosciences started this device recall on 5 Oct 2020. The firm address in the FDA record is in San Jose, CA. FDA put the recall in Class II. FDA event 86655 has 1 product record. The first FDA enforcement report date is 16 Dec 2020. The record gives the status Terminated, with the termination date 11 Mar 2022.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, NC, NJ, NV, NY, OH, OK, PA, PR, RI, SD, TN, TX, and VA. The…

Recalling firm

Becton, Dickinson and Company, BD Biosciences, San Jose, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 86655: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0562-2021	BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.	619 vials	Class II	Terminated	16 Dec 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 22

Other events of the firm

Other FDA enforcement events of Becton, Dickinson and Company, BD Biosciences
Initiated	Product (first record)	Type	Class	Records
8 May 2024	BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166;	Device	Class II	1
25 Oct 2023	CD11b APC: ASR, REF: 340936, and CE, REF: 333143	Device	Class II	1
3 Oct 2022	BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are	Device	Class II	3
25 Mar 2022	BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recog	Device	Class II	2
22 Jul 2021	BD" Mouse IgG2a Isotype Control APC X39 ASR	Device	Class II	1
31 Mar 2020	Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (	Device	Class II	1
19 Aug 2019	BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes	Device	Class II	9
8 Jul 2019	BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical soft	Device	Class II	3
2 Jan 2019	BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flo	Device	Class III	1
16 May 2018	BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The f	Device	Class III	1

Becton, Dickinson and Company, BD Biosciences: all 22 events

Official channels

FDA enforcement report Z-0562-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 86655. https://recallregister.com/fda/ii/86655/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, NC, NJ, NV, NY, OH, OK, PA, PR, RI, SD, TN, TX, and VA. The…
What quantity of product is in FDA event 86655?: The FDA record gives this quantity: 619 vials
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.