Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-1444-2015

March 04, 2015

Class II

Product summary

Firm
Hardy Diagnostics
Event
Event 70767
Status
Terminated
Classification
Class II
Quantity
840 (84 pk/10)
Official record key
device-enforcement:Z-1444-2015

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.