Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm

FDA device recall Z-1444-2015 · posted 2015-04-14 · Terminated

Recall details

Recalling firm

Hardy Diagnostics

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.

Action taken

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 techservice@hardydiagnostics.com.

Root cause

Employee error

Status

Terminated

Product code

JSI

Quantity affected

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.

Date initiated

2015-03-04

Date posted

2015-04-14

Date terminated

2015-07-13

Location

Santa Maria, CA