FDA Medical Device Recalls (openFDA)
Becton, Dickinson and Company, BD Biosciences: BD" Mouse IgG2a Isotype Control APC X39 ASR
- Recall number
- Z-2333-2021
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Product
- BD" Mouse IgG2a Isotype Control APC X39 ASR
- Status
- Terminated
- Initiated
- 2021-07-22
- Posted
- not on file
- Terminated
- 2023-03-24
- Reason
- 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
- 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
- 23 reagents
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.
- Lot, serial or model codes
- Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 2916837
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28