Recall Z-1444-2015 ยท JSI Culture Media, Selective And Differential
Hardy Diagnostics
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.
| Date | Apr 14, 2015 (initiated Mar 4, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| 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 fu |
| Quantity | 840 (84 pk/10) |
| Distribution | Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.