Class 3 Device Recall

• Date Initiated by Firm: February 04, 2005
• Date Posted: February 28, 2006
• Recall Status: Terminated on February 01, 2007
• Recall Number: Z-0563-06
• Recall Event ID: 34385
• Product Classification: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use - Product Code JQC
• Product: Centrifuge Model CF-6 with lid lock. (Block Model number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Cascade.
• Code Information: Serial Numbers: For MTF: -- 034135 through 034144; For Cascade -- 034119 through 034128.
• FEI Number: 1000121662
• Recalling Firm/ Manufacturer: Cygnus LLC; 510 E 41st St; Paterson NJ 07504-1210
• For Additional Information Contact: Mr. James Kearney; 973-523-0668
• Manufacturer Reason for Recall: The units were exhibiting tolerance stacking in the electronic circuit timer that controls the electric motor that spins the centrifuge and applies the centrifuge brake.
• FDA Determined Cause: Other
• Action: A recall notificaiton was sent to the firm''s customers by e-mail on 2/14/2005. Distributor conducted sub-recall.
• Quantity in Commerce: 20 units
• Distribution: All product was shipped domestically to the firm''s distributor, Bock Scientific, 1170 Lincoln Avenue, Unit 11, Holbrook, NY 11741
• 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.