BD" Mouse IgG2a Isotype Control APC X39 ASR recallZ-2333-2021 · Becton, Dickinson and Company, BD Biosciences · initiated Jul 22, 2021
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
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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
Recall details
- Recall number
- Z-2333-2021
- Status
- Terminated
- Initiated by the company
- Jul 22, 2021
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Quantity
- 23 reagents
- Product code
- MVU
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.
Product description
BD" Mouse IgG2a Isotype Control APC X39 ASR
Code information (models, lots, serial numbers)
Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/A 340757Becton, Dickinson And Company · Reagents, specific, analyte1 recall1 report
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 16, 2026. Text above is shown as published by the FDA.
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