Remel Inc: Medical Device Recall in 2013 - (Recall #: Z-0538-2014)

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* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci

Product Classification:

Class II

Date Initiated: May 2, 2013

Date Posted: December 25, 2013

Recall Number: Z-0538-2014

Event ID: 65476

Reason for Recall:

The product may give weak or false negative test results.

Status: Terminated

Product Quantity: 109 kits

Code Information:

Lot 1149576, exp January 2014

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated