Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on
FDA device recall Z-2057-2014 · posted 2014-07-15 · Terminated
Recall details
- Recalling firm
- Remel Inc
- 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.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 76/50-bottle boxes
- Distribution
- Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.
- Date initiated
- 2014-06-11
- Date posted
- 2014-07-15
- Date terminated
- 2014-08-28
- Location
- Lenexa, KS
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERSATREK (K032306) | Trek Diagnostic Systems, Inc. | 2003-08-22 |