Device product
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.
Z-2057-2014
Product summary
- Firm
- Remel Inc
- Event
- Event 68583
- Status
- Terminated
- Classification
- Class II
- Quantity
- 76/50-bottle boxes
- Official record key
device-enforcement:Z-2057-2014
Official wording
Reason: Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
Code information: Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10
Distribution pattern: Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.
Derived failure modes
-
Unknown
Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.