FDA-Device2014-07-23Class II

Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.

Remel Inc
Hazard

Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.

Sold states
Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.
Affected count
76/50-bottle boxes
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2057-2014

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