Z-2333-2021Class II

BD" Mouse IgG2a Isotype Control APC X39 ASR

Name: Z-2333-2021 BD" Mouse IgG2a Isotype Control APC X39 ASR
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2021-07-22
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2021-07-22 / Terminated / root cause: manufacturing process

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of BD" Mouse IgG2a Isotype Control APC X39 ASR on 2021-07-22. FDA classified it as Class II and gives the reason as "Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to...". 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-2333-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-22
Posted: 2021-08-24
Terminated: 2023-03-24
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD" Mouse IgG2a Isotype Control APC X39 ASR
Product code: MVU Reagents, Specific, Analyte
Reason for recall: Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 07/22/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification letter via FedEx to customers to inform them that the Recalling Firm received 3 complaints for performance issues related to high background and staining. Our investigation has confirmed there was an error during the manufacturing process that can potentially cause a false positive staining due to contamination with another antibody. Customers are instructed to: 1) Immediately review their inventory for the specific Catalog and lot number listed in the Recall Notification above. Destroy all product subject to the recall following their institution 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. If the affected product was used to generate test results, review potential impact to test results following their institution's policies. 3) Complete the attached Customer Response Form and return to the BD contact noted on the form. Even if you do not have any of the affected lots in your inventory, please complete the Customer Recall Response Form indicating you have zero (0) quantity and return as indicated. Actions being taken by the Recalling Firm: 1) An investigation has been initiated to identify root cause and corrective actions to prevent recurrence. 2) The Recalling Firm will provide replacement for any discarded product. For questions or additional assistance contact North American Regional Complaint Center at 1-844-8BD-LIFE (1-844-823-5433) M-F 8am -5pm CT
Quantity in commerce: 23 reagents
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.
Product codes and lots: Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2333-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2333-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-24

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)