Remel Inc: Medical Device Recall in 2013 - (Recall #: Z-0537-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 2, 2013

Date Posted: December 25, 2013

Recall Number: Z-0537-2014

Event ID: 65476

Reason for Recall:

The product may give weak or false negative test results.

Status: Terminated

Product Quantity: 768 kits

Code Information:

Lot 1192181, exp. January 2014

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated