Date Initiated by Firm | August 08, 2016 |
Date Posted | June 01, 2017 |
Recall Status1 |
Terminated 3 on June 02, 2017 |
Recall Number | Z-2212-2017 |
Recall Event ID |
77281 |
Product Classification |
Culture media, non-selective and non-differential - Product Code JSG
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Product | Sabouraud Dextrose Agar w /Lecithin and Tween 20
Acumedia PN 91081
Product Usage:
Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds |
Code Information |
PN 91081C, Lot 108367A PN 91081C, Lot 107632A |
Recalling Firm/ Manufacturer |
Acumedia Manufacturers, Inc. 740 E Shiawassee St Lansing MI 48912-1218
|
For Additional Information Contact | John Guenther 800-234-5333 Ext. 2362 |
Manufacturer Reason for Recall | Storage temperature listed on the label was incorrect. Label stated
2-30C. Actual storage temperature is 2-8C. |
FDA Determined Cause 2 | Error in labeling |
Action | On 8/8/2016 and 10/6/2016, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product. |
Quantity in Commerce | 10 units |
Distribution | US in the state of IL |
Total Product Life Cycle | TPLC Device Report |
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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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