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Terminated

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.

FDA Recall Z-1444-2015 · Posted 2015-04-14

Recalling FirmHardy Diagnostics
Recall StatusTerminated
Product CodeJSI
Date Initiated2015-03-04
Date Terminated2015-07-13
Product Quantity840 (84 pk/10)

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.

Firm Action

On 03/12/2015 the firm sent recall notification letters to customers. The firm's letter informs customers of the reason for recall, and requests that they discard any remaining stock of the recalled lot. The firm continues to request that even though the customer has been informed of the necessary actions that they still take a moment to complete, sign, and fax back the enclosed form stating their compliance with the above action to the attention of their Quality Assurance Department at (805) 614-9274. The firm stated that the form is required for their records and need to document the full quantity received, used and/or discarded. For replacements or credit to please contact the Customer Service Department at (800) 266-2222 and select option 1. The firm states that replacements will be sent out at no charge to customers, or a credit will be applied to the invoice. For any additional questions the firm states to contact Technical Services at (800) 266-2222, option 2 or e-mail at [email protected].

Root Cause

Employee error

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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