Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoie
Summary
The FDA issued a Class III for Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative contr by R & D Systems, Inc.. Reason: 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..
Details
Source
Device Recall
External ID
Z-1390-2022
Action Date
2022-07-27
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: UDI 00815762021671, Lot Codes: P301801; P304262; P306132; P310038; P314685; P320216; P322531 Expiration Date: 08/04/2023
Quantity Affected: 400
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-14
Company
Minneapolis, MN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
R & D Systems, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (R & D Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does R & D Systems, Inc. have FDA actions?
R & D Systems, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1390-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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