Z-0103-2012

Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96...

Name: Z-0103-2012 Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96...
Creator: Hamilton Co
Published: 2011-09-26
License: https://open.fda.gov/license/

Hamilton Co / initiated 2011-09-26 / Terminated / root cause: manufacturing process

FDA source

Hamilton Co began a recall of 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... on 2011-09-26. The reason FDA records is "Certain lots of syringes have caused an increase in error message "DIS541", which indicates "improper dispensation"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0103-2012
Status: Terminated
Initiated: 2011-09-26
Posted: 2011-10-21
Terminated: 2012-03-06
Recalling firm: Hamilton Co
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Certain lots of syringes have caused an increase in error message "DIS541", which indicates "improper dispensation".
Root cause tag: manufacturing process
FDA 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 [email protected]. 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.
Product codes and lots: Lots: 30311; 50411; 30511; 50611; 50711; 50811; 30911; 50911; 51011; 31111; 51111;31211; 51211; 31311; 51311

Product code JJE

K943493Class IDiscrete Photometric Chemistry AnalyzerHamilton Co. / cleared 1995-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)