Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BD" Mouse IgG2a Isotype Control APC X39 ASR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall BD" Mouse IgG2a Isotype Control APC X39 ASR see related information
Date Initiated by Firm July 22, 2021
Create Date August 24, 2021
Recall Status1 Terminated 3 on March 24, 2023
Recall Number Z-2333-2021
Recall Event ID 88341
Product Classification Reagents, specific, analyte - Product Code MVU
Product BD" Mouse IgG2a Isotype Control APC X39 ASR
Code Information Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Larry Perruzza
609-216-9971
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-