| Class 2 Device Recall BD FACS Sample Prep Assistant II (SPA II) |  |
Date Initiated by Firm | February 19, 2010 |
Date Posted | June 30, 2010 |
Recall Status1 |
Terminated 3 on May 18, 2011 |
Recall Number | Z-1940-2010 |
Recall Event ID |
55654 |
510(K)Number | K050191 |
Product Classification |
blood sample preparer for flow cytometry analysis - Product Code GKZ
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Product | BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis |
Code Information |
Sample Probe Catalog Numbers 337170, 333494, 333485, 339118, 647768, 647769, and lot numbers , 92035 and 92036. |
Recalling Firm/ Manufacturer |
BD Biosciences, Systems & Reagents 2350 Qume Dr San Jose CA 95131-1812
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For Additional Information Contact | 408-954-6307 |
Manufacturer Reason for Recall | Samples prepared on the BD SPA II, SN T0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | The firm filed an MDR and implemented a field action consisting of a February 2010 notification letter and product replacement of affected probes. A CAPA for the probe design has been implemented. Effectivity is being tracked via mail and follow up phone call. |
Quantity in Commerce | 349 units |
Distribution | Worldwide distribution: USA, Australia, Belgium, China (Hong Kong), Colombia, Jamaica, Korea, Mexico, Singapore and Uruguay. |
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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