Reported Aug 8, 2018 · Terminated
BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The…
Becton, Dickinson and Company, BD Biosciences
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton, Dickinson and Company, BD Biosciences · 2350 Qume Dr · San Jose, CA · 95131-1812
Is this the product you have?
- 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.
- Lot codes and dates
10 of 10 products
Products covered by this recall # Barcodes Product as published 1 266287900000100382906628794Serial #2662879000001, UDI (01)00382906628794(11)170915(21)Z662879000001 2 266287900000200382906628794Serial #2662879000002, UDI (01)00382906628794(11)170915(21)Z662879000002 3 266287900000300382906628794Serial #2662879000003, UDI (01)00382906628794(11)170915(21)Z662879000003 4 266287900000400382906628794Serial #2662879000004, UDI (01)00382906628794(11)170915(21)Z662879000004 5 266287900000900382906628794Serial #2662879000009, UDI (01)00382906628794(11)170915(21)Z662879000009 6 2662879000010Serial #2662879000010 7 00382906628794UDI (01)00382906628794(11 )170915(21)Z662879000010 8 2662879000011Serial #2662879000011 9 00382906628794UDI (01)00382906628794(11)170915(21)Z662879000011 10 266287900001200382906628794and Serial #2662879000012, UDI (01)00382906628794(11)170915(21)Z662879000012. - Amount recalled
- 8 devices
Where it was sold
Why it was recalled
The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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