Recall Z-2057-2014 ยท MDB System, Blood Culturing
Remel Inc
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.
| Date | Jul 15, 2014 (initiated Jun 11, 2014) |
| Status | Terminated |
| Reason | Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 76/50-bottle boxes |
| Distribution | Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032306 | VERSATREK Trek Diagnostic Systems, Inc., Aug 22, 2003 |