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U.S. Department of Health and Human Services

Class 2 Device Recall Gibco GlutaMAX Supplement

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  Class 2 Device Recall Gibco GlutaMAX Supplement see related information
Date Initiated by Firm August 24, 2018
Create Date October 17, 2018
Recall Status1 Terminated 3 on April 29, 2020
Recall Number Z-0174-2019
Recall Event ID 81052
Product Classification Media and components, synthetic cell and tissue culture - Product Code KIT
Product Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use
SKU 35050061
Code Information Lot Number: 1967697 (UDI 10190302001823) Exp. Date: 30-Jun-2020 
Recalling Firm/
Manufacturer		 Life Technologies, Corp.
3175 Staley Rd
Grand Island NY 14072-2028
For Additional Information Contact Chance Lai
240-379-4394
Manufacturer Reason
for Recall		 Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
FDA Determined
Cause 2		 Under Investigation by firm
Action Thermo Fisherr issued Urgent Medical Device Recall Notification Letter with a customer response sheet sent to consignees via FedEx on 24-Aug-2018. Consignees have been instructed to discard affected product per local and state requirements, or return the affected product to Thermo Fisher Scientific. All consignees are instructed to complete the attached Customer Response Sheet. Thermo Fisher Scientific will issue a no-cost replacement for the recalled product. In addition, consignees are instructed to review results and laboratory reporting associated with use of the affected product for further action. Consignees should notify any personnel who need to be aware of the potential for failure of performance for this product. Questions: contact Technical Services Department at 800-955-6288 Option 2.
Quantity in Commerce 1912 units
Distribution Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan
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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