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U.S. Department of Health and Human Services

Class 2 Device Recall Gibson Bioscience Blastomyces dermatitidis Antiserum

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  Class 2 Device Recall Gibson Bioscience Blastomyces dermatitidis Antiserum see related information
Date Initiated by Firm January 20, 2017
Create Date February 14, 2018
Recall Status1 Terminated 3 on February 20, 2018
Recall Number Z-0606-2018
Recall Event ID 78731
Product Classification Antiserum, blastomyces dermatitidis, other - Product Code LSI
Product Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265

Intended for identification of the systemic fungal pathogens.
Code Information Lot # 5072543 Exp Date 03/12/2021; UDI : 10634853000039.
Recalling Firm/
Manufacturer		 Gibson Laboratories LLC
1040 Manchester St
Lexington KY 40508-2422
For Additional Information Contact Mrs. Penny B. Epperson
859-303-5169
Manufacturer Reason
for Recall		 The firm information that the product was reporting false positive results
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On January 20, 2017, the firm sent Urgent Medical Device Recall notification letter and response form to their customers. The letter identified the affected and the reason for the recall. Users are instructed not to use any Blastomyces dermatitidis (catalog # 200265) that they may have in inventory and to quarantine any affected product. Return any affected product per the instructions provided; and, complete and return the attached acknowledgement form. Questions regarding this recall should be directed to Penny Epperson, Quality Manager, at 859-303-5169 or pepperson@gibsonlabs.com.
Quantity in Commerce 10/1 mL vials
Distribution Distributed to the states of AL, AZ & MS.
Total Product Life Cycle TPLC 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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