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U.S. Department of Health and Human Services

Class 3 Device Recall QUANTIKINE ERYTHROPOIETIN HUMAN SERUM CONTROLS

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  Class 3 Device Recall QUANTIKINE ERYTHROPOIETIN HUMAN SERUM CONTROLS see related information
Date Initiated by Firm June 14, 2022
Date Posted July 15, 2022
Recall Status1 Open3, Classified
Recall Number Z-1390-2022
Recall Event ID 90445
510(K)Number K931756  
Product Classification Assay, erythropoietin - Product Code GGT
Product Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095
Code Information Lot Code: UDI 00815762021671, Lot Codes: P301801; P304262; P306132; P310038; P314685; P320216; P322531 Expiration Date: 08/04/2023
Recalling Firm/
Manufacturer		 R & D Systems, Inc.
614 Mckinley Pl Ne
Minneapolis MN 55413-2610
Manufacturer Reason
for Recall		 The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is followed by the Notified Body designation, British Standards Institution number 2797 (BSI-2797) for product inserts 750095.28 and 750095.29. The erroneous label CE2797 were in the IFU insert revision 750095.28 for the 408 affected lots that were shipped. No product was packed with erroneous insert revision 750095.29. Since the product is currently CE marked as a Class I - self-certified product under the EU In Vitro Diagnostics Directive, the Notified Body designation should not be specified. As part of the corrective action, the firm has notified the customers who received the products with erroneous labeling, and is conducting the replacements with the correct product insert containing the Insert Revision 750095.30
FDA Determined
Cause 2		 Process control
Action The firm notified its consignees on 06/14/2022 by email. Distributors were directed to notify their customers. Users were directed to destroy any inventory.
Quantity in Commerce 400
Distribution Worldwide distribution - US Nationwide distribution in the states of FL, MN, UT, OH, MA, TX, PR, PA, NJ, CA, WI, LA, Puerto Rico, and the countries of CANADA, UNITED KINGDOM, ISRAEL, MEXICO, THAILAND, CHINA, HONG KONG, AUSTRALIA, INDONESIA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GGT and Original Applicant = R & D SYSTEMS, INC.
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