Recall Z-2057-2014
Remel Inc · initiated June 11, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10
Reason for recall
Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
FDA-determined cause: Employee error
Action taken
The recalling firm made phone calls to their customers beginning 6/11/14 with follow-up letters dated 6/12/14 being issued via regular mail requesting the affected product be destroyed. Additional customers were later identified and additional phone calls were made on 6/16/14 and recall letters dated 6/16/14 were issued via regular mail.
Details
- Recall number
- Z-2057-2014
- Initiated
- June 11, 2014
- Posted by FDA
- July 15, 2014
- Terminated
- August 28, 2014
- Product code
- MDB – System, Blood Culturing
- Quantity
- 76/50-bottle boxes
- Distribution
- Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.
- Recalling firm
- Remel Inc, Lenexa, KS