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Class 2 Device Recall BD AntiKappa PE |
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Date Initiated by Firm |
March 25, 2022 |
Create Date |
June 01, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1215-2022 |
Recall Event ID |
90028 |
Product Classification |
Reagents, specific, analyte - Product Code MVU
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Product |
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry. |
Code Information |
Lot # 1228977; UDI: 00382903465873 |
Recalling Firm/ Manufacturer |
Becton, Dickinson and Company, BD Biosciences 2350 Qume Dr San Jose CA 95131-1812
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For Additional Information Contact |
North Americal Regional Complaint Center 1844-823-5499
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Manufacturer Reason for Recall |
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
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FDA Determined Cause 2 |
Process control |
Action |
On April 20, 2022, BD Biosciences issued a "Urgent Product Recall" notification via FeDEx to affected consignees. The firm ask consignees to take the following actions:
1. Immediately review your inventory for the specific Catalog and lot numbers listed above. Destroy all product subject to the recall following your institution s process for destruction.
2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall.
3. If the product was used in LDTs to generate patient results, please also review potential impact to patient results following your institution s policies.
4. 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.
5. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via the: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) or Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 |
Quantity in Commerce |
199 units |
Distribution |
Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, DC, DE, FL, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, NC, ND, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and the country of Taiwan. |
Total Product Life Cycle |
TPLC Device Report
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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