Recall Z-0103-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Hamilton Co
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 instrument
| Date | Oct 21, 2011 (initiated Sep 26, 2011) |
| Status | Terminated |
| Reason | Certain lots of syringes have caused an increase in error message "DIS541", which indicates "improper dispensation". |
| Root cause | 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 Direct |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943493 | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER Hamilton Co., Jan 30, 1995 |