Fisher Scientific Co., LLC
United StatesFDA applicant, unverified
- Devices
- 90
- FDA recalls
- 2
What Fisher Scientific Co., LLC makes
Fisher Scientific Co., LLC produces laboratory reagents and calibrating solutions for clinical diagnostics and hematology equipment, including specific formulations for devices like the Coulter Counter, Radiometer osmometers, and ABL blood gas analyzers. Their portfolio also covers electrolyte and protein measurement reagents, creatinine determination kits, and cleaning solutions for electrodes and analytical instruments.
The company’s products are regulated under FDA classifications, with devices spanning Class I, Class II, and Class III. Authorisation records include 510(k) clearances and PMA submissions, and the portfolio is listed in the FDA’s regulatory databases. The manufacturer is based in the United States.
Catalogue
Search and filter all 90 devicesShowing 51-90 of 90
FDA recalls
FDA recall records list 2 recalls initiated by Fisher Scientific Co., LLC, the earliest on 2013-06-05 and the most recent on 2014-02-05. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 5 Feb 2014 Z-1521-2014 Class II Terminated A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab.
2013
- 5 Jun 2013 Z-1955-2013 Class II Terminated The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.