—#119039

Product

Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.

FDA product code: JTO — Discs, Strips And Reagents, Microorganism Differentiation
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K842828
Affected lot / code info: Lot 1192181, exp. January 2014

Why it was recalled

The product may give weak or false negative test results.

Root cause (FDA determination)

Process control

Action the firm took

ThermoFisher sent a Medical Device Recall letter dated April 26, 2013, or May 2, 2013, to all affected customers via first class mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false negative test result, review their inventory for affected product lots and discard the affected product. Customers were also instructed to return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-888-0939.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2013-05-02
Posted by FDA: 2013-12-18
Terminated: 2014-03-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119039. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.