Date Initiated by Firm | March 31, 2016 |
Create Date | April 26, 2016 |
Recall Status1 |
Terminated 3 on May 26, 2017 |
Recall Number | Z-1570-2016 |
Recall Event ID |
73748 |
510(K)Number | K970836 |
Product Classification |
Counter, differential cell - Product Code GKZ
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Product | BD Trucount Absolute Counting Tubes:
Model number: 340334
IVD;
BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader. |
Code Information |
Model: 340334; Manufacaturing lot: 534964 |
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 | Melissa J. Quinn 408-954-6080 |
Manufacturer Reason for Recall | One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used. |
FDA Determined Cause 2 | Packaging |
Action | BD Biosciences sent an Urgent Product Recall letter dated March 2016 to all affected customers on March 31, 2016 by Certified Mail, e-mail and direct delivery by Sales Associates.
Letters instructed that any remaining inventory of the affected lot be discarded and that date files obtained using reagents from the affected lot be reviewed for the possibility of incorrect data.
Customers with questions were instructed to contact BD Customer Support at 877-232-8995 (prompt3, 3) in the united State. For customers outside the US, customers should contact their local BD Biosciences representative or distributor.
For questions regarding this recall call 408-954-6080. |
Quantity in Commerce | 1743; 467 US and 1276 International |
Distribution | Worldwide Distribution - US including MD, CA GA. WA. PA. CO. TN. FL. NC. DE. VA, CT, LA. NC, NY, OH, MN, NH and Internationally to China, Japan, and India. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GKZ
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