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U.S. Department of Health and Human Services

Class 3 Device Recall Disposable Syringe Pack for use with Microlab F.A.M.E

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 Class 3 Recall
Disposable Syringe Pack for use with Microlab F.A.M.E
see related information
Date Posted October 21, 2011
Recall Status1 Terminated on March 06, 2012
Recall Number Z-0103-2012
Recall Event ID 60047
Premarket Notification
510(K) Number
K943493 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.
Code Information Lots: 30311; 50411; 30511; 50611; 50711; 50811; 30911; 50911; 51011; 31111; 51111;31211; 51211; 31311; 51311
Recalling Firm/
Manufacturer
Hamilton Co
4970 Energy Way
Reno, Nevada 89502-4123
For Additional Information Contact Wayne McAuliffe
775-858-3000 Ext. 236
Manufacturer Reason
for Recall
Certain lots of syringes have caused an increase in error message "DIS541", which indicates "improper dispensation".
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, Hamilton, sent an "Urgent: Product Recall Notification" letter dated September 26, 2011 to its customers. The letter describes the product, problem and action to be taken. The customers were instructed to return the syringes with a completed Hamilton Company Product Recall Questionnaire form via fax to: (775) 856-7259 or with an emailed signed pdf copy to wayne.mcauliffe@hamiltoncompany.com. The firm's Customer Service Department will contact customers with complete Returned Material Authorization information. If you have any questions, please do not hesitate to contact the Director of Quality at (775) 858-3000.
Quantity in Commerce 1096 units
Distribution Worldwide distribution: USA(nationwide) including states of: NJ, NV, TX and WA; and countries of: Brazil, P.R. China, France and Germany.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = HAMILTON CO.
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