Remel Inc: Medical Device Recall in 2015 - (Recall #: Z-2351-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.

Product Classification:

Class II

Date Initiated: June 30, 2015

Date Posted: August 19, 2015

Recall Number: Z-2351-2015

Event ID: 71614

Reason for Recall:

A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.

Status: Terminated

Product Quantity: 4420 bottles

Code Information:

lot 1463129, exp. date 31 May 2016

Distribution Pattern:

Nationwide Distribution, including Puerto Rico and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated