—#128265

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.

FDA product code: MDB — System, Blood Culturing
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K032306
Affected lot / code info: Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.

Timeline

Recall initiated: 2014-06-11
Posted by FDA: 2014-07-15
Terminated: 2014-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128265. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.