Hardy Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-1444-2015)

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:

Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.

Product Classification:

Class II

Date Initiated: March 4, 2015

Date Posted: April 22, 2015

Recall Number: Z-1444-2015

Event ID: 70767

Reason for Recall:

The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot.

Status: Terminated

Product Quantity: 840 (84 pk/10)

Code Information:

Lot no. 15037, Expires: 00-00-2000

Distribution Pattern:

Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.

Voluntary or Mandated:

Voluntary: Firm initiated