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U.S. Department of Health and Human Services

Class 2 Device Recall HardyCHROM SS Agar

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 Class 2 Device Recall HardyCHROM SS Agarsee related information
Date Initiated by FirmMarch 04, 2015
Date PostedApril 14, 2015
Recall Status1 Terminated 3 on July 13, 2015
Recall NumberZ-1444-2015
Recall Event ID 70767
Product Classification Culture media, selective and differential - Product Code JSI
ProductHardy 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.
Code Information Lot no. 15037, Expires: 00-00-2000 
Recalling Firm/
Manufacturer		 Hardy Diagnostics
1430 W Mccoy Ln
Santa Maria CA 93455-1005
For Additional Information ContactTechnical Services
800-266-2222
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionOn 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 techservice@hardydiagnostics.com.
Quantity in Commerce840 (84 pk/10)
DistributionWorldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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