Devices

Disposable Syringe Pack for use with Microlab F.A.M.E

Model / Serial
Lots: 30311; 50411; 30511; 50611; 50711; 50811; 30911; 50911; 51011; 31111; 51111;31211; 51211; 31311; 51311
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA(nationwide) including states of: NJ, NV, TX and WA; and countries of: Brazil, P.R. China, France and Germany.
Product Description
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.
Manufacturer
Hamilton Co
1 Event
- Recall of Disposable Syringe Pack for use with Microlab F.A.M.E

Manufacturer

Hamilton Co

Manufacturer Address
Hamilton Co, 4970 Energy Way, Reno NV 89502-4123
Source
USFDA

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