Recall Z-1620-2011 ยท JQW Station, Pipetting And Diluting, For Clinical Use
BD Biosciences, Systems & Reagents
BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, Model Number: 334080, Product is manufactured and distributed by BD Biosciences, San Jose, CA The intended use for the BD FACS Sample Prep Assistant (SPA and SPA II) is to prepare human whole blood for flow cytometry.
| Date | Jan 3, 2009 |
| Status | Terminated |
| Reason | To prevent a needle stick while replacing the probe, the firm has initiated a Field Correction, and issued an improved Users Guide procedure (User Bulletin, Part Number 645050). |
| Root cause | Nonconforming Material/Component |
| Action | The firm, BD Biosciences, sent an information letter dated December 2008 with an enclosed New Probe Replacement Service/User Bulletin, to the customers. The letter described the product, problem and action to be taken. The customers were instructed to review the attached User Bulletin (Part Number 645050); ensure that their laboratory follows the updated procedure for removing and replacing probe; place the User Bulletin in their BD FACS SPA or SPA II User's Guide; always follow the instructions in User Bulletin to properly remove and replace probe, and complete and return the Effectivity Form |
| Quantity | 70 |
| Distribution | Worldwide distribution: USA and countries including: Hong Kong, Australia, Belgium, Canada, El Salvador, Hong Kong, Japan, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.