Medical device recalls Moderate risk

Hardy Diagnostics cat no recalled over Salmonella risk

Recall date
March 4, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Hardy Diagnostics recalls Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100m…
Recall number
Z-1444-2015
FDA classification
Class II
Brand / firm
Hardy Diagnostics
Sold / distributed
Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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