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U.S. Department of Health and Human Services

Class 3 Device Recall BD FACS Universal Loader

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  Class 3 Device Recall BD FACS Universal Loader see related information
Date Initiated by Firm May 16, 2018
Date Posted July 13, 2018
Recall Status1 Terminated 3 on August 13, 2018
Recall Number Z-2598-2018
Recall Event ID 80388
510(K)Number K170974  
Product Classification Flow cytometric reagents and accessories. - Product Code OYE
Product BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA.

The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.
Code Information Serial #2662879000001, UDI (01)00382906628794(11)170915(21)Z662879000001;   Serial #2662879000002, UDI (01)00382906628794(11)170915(21)Z662879000002;   Serial #2662879000003, UDI (01)00382906628794(11)170915(21)Z662879000003;   Serial #2662879000004, UDI (01)00382906628794(11)170915(21)Z662879000004;   Serial #2662879000009, UDI (01)00382906628794(11)170915(21)Z662879000009;   Serial #2662879000010; UDI (01)00382906628794(11 )170915(21)Z662879000010;   Serial #2662879000011; UDI (01)00382906628794(11)170915(21)Z662879000011; and   Serial #2662879000012, UDI (01)00382906628794(11)170915(21)Z662879000012.            
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Ms. Gail M. Griffiths
410-316-4054
Manufacturer Reason
for Recall		 The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, BD Life Sciences, produced the "URGENT PRODUCT RECALL-CORRECTION" letter dated 4/6/2018 to its customers during an on-site visit. by the field service engineer made beginning 5/16/2018 to correct the issue. The visits were completed 6/15/2018. If you require further assistance, contact BD Customer/Technical Support BD Customer Support at 877.232.8995 (prompt 2) for instruments in the United States. For customers outside the US, contact your local BD representative or distributor.
Quantity in Commerce 8 devices
Distribution US Distribution was made to FL, KS, KY, MA, NJ, and SD.
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.
510(K) Database 510(K)s with Product Code = OYE and Original Applicant = Becton, Dickinson and Company
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