Recall Z-0103-2012
Hamilton Co · initiated September 26, 2011
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.
Codes / lots: Lots: 30311; 50411; 30511; 50611; 50711; 50811; 30911; 50911; 51011; 31111; 51111;31211; 51211; 31311; 51311
Reason for recall
Certain lots of syringes have caused an increase in error message "DIS541", which indicates "improper dispensation".
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0103-2012
- Initiated
- September 26, 2011
- Posted by FDA
- October 21, 2011
- Terminated
- March 6, 2012
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 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.
- Recalling firm
- Hamilton Co, Reno, NV