| Class 2 Device Recall Thermo Scientific VersaTREK REDOX 1, Ref 710244 | |
Date Initiated by Firm | June 11, 2014 |
Date Posted | July 15, 2014 |
Recall Status1 |
Terminated 3 on August 28, 2014 |
Recall Number | Z-2057-2014 |
Recall Event ID |
68583 |
510(K)Number | K032306 |
Product Classification |
System, blood culturing - Product Code MDB
|
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. |
Code Information |
Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10 |
Recalling Firm/ Manufacturer |
Remel Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
|
For Additional Information Contact | Earleen C. Parks 913-895-4185 |
Manufacturer 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 2 | 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 in Commerce | 76/50-bottle boxes |
Distribution | Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = MDB
|
|
|
|