Z-0562-2021Class II

BD" Multi-Check CD4 Low Control 2.5 mL IVD -

Name: Z-0562-2021 BD" Multi-Check CD4 Low Control 2.5 mL IVD -
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2020-10-05
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2020-10-05 / Terminated / root cause: manufacturing process

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry on 2020-10-05. FDA classified it as Class II and gives the reason as "Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0562-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-05
Posted: 2020-12-10
Terminated: 2022-03-11
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
Product code: JPK Mixture, Hematology Quality Control
Reason for recall: Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 10/13/2020, the firm notified it customer via telephone and sent an "URGENT MEDICAL DEVICE RECALL" Notification via email and/or FedEx to inform them that complaints have been report regarding their Low Control product which shows an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate gating with the potential for delayed patient management. Customer are instructed to: 1. Immediately review their inventory for the specific Catalog and lot numbers listed. Destroy all product subject to this recall following their institutions process for destruction. 2. Share this recall notification with all users of the product within their facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the Recalling Firm contact noted on the form. Even if customer do not have any of the affected lots in their inventory, they are asked to complete the Customer Recall Response Form indicating they have zero (0) quantity and return as indicated. Return Customer Response Form via email [email protected] or fax 312-949-0371 Actions the Recalling Firm is taking: An investigation has been initiated to identify root cause and corrective actions to prevent recurrence. An questions, contact Customer/Technical Support at 877-232-8995 (prompt 2,2)
Quantity in commerce: 619 vials
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 countries of Canada, Belgium, Korea, India, Ecuador, Japan, Costa Rica, Australia, Vietnam, Pakistan, Singapore, Thailand, and Peru.
Product codes and lots: Lot Number: BM1020L BD Multi-Check CD4 Low Control (US Distribution) Catalog Number UDI 349703 00382903497034 US 349704 00382903497041 US 349705 00382903497058 US BD" Multi-Check CD4 Low Control Whole Blood Control for Lymphocyte Subset Enumeration OUS Distribution Catalog Number UDI 340914 00382903409143 OUS only 340915 00382903409150 OUS only 340916 00382903409167 OUS only

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0562-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0562-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-10

Product code JPK

K150815Class IIBD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge KitBecton, Dickinson and Company / cleared 2015-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)