Fisher Scientific Co., LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 90
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
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 1-50 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.
Frequently asked questions
How many devices does Fisher Scientific Co., LLC have in the registry?
The registry currently lists 90 devices for Fisher Scientific Co., LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fisher Scientific Co., LLC's devices?
Among its 50 most recently registered devices, Fisher Scientific Co., LLC has devices listed in FDA 510(k) (50 devices).
What risk classes do Fisher Scientific Co., LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Fisher Scientific Co., LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Fisher Scientific Co., LLC?
FDA recall records list 2 recalls initiated by Fisher Scientific Co., LLC, the most recent initiated on 2014-02-05. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Fisher Scientific Co., LLC in the registry?
The most recently registered devices listed for Fisher Scientific Co., LLC include TOTAL BILIRUBIN, CALIBRATING SOLUTION FOR ABL-1 & 2, REAGENT FOR COULTER COUNTER MODEL 5+11 and TOTAL PROTEIN REAGENT CS-724.