BD Multi-Check recallZ-0562-2021 · Becton, Dickinson and Company, BD Biosciences · initiated Oct 5, 2020
Class II Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton, Dickinson and Company, BD Biosciences or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
FDA root cause category: Process control
What the company is doing
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)
Recall details
- Recall number
- Z-0562-2021
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 5, 2020
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Quantity
- 619 vials
- Product code
- JPK
- FDA submissions
- K150815
- 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 description
BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
Code information (models, lots, serial numbers)
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
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- BD™ Multi-Check 340914Becton, Dickinson And Company · Counter, differential cell1 recall2 reports
- BD Multi-Check 349703Becton, Dickinson And Company · Mixture, hematology quality control1 recall1 report
- BD Multi-Check 349704Becton, Dickinson And Company · Mixture, hematology quality control1 recall1 report
- BD™ Multi-Check 340915Becton, Dickinson And Company · Counter, differential cell1 recall0 reports
- BD™ Multi-Check 340916Becton, Dickinson And Company · Counter, differential cell1 recall0 reports
- BD Multi-Check 349705Becton, Dickinson And Company · Mixture, hematology quality control1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page