R & D Systems, Inc. Recall 90445
Description: Quantikine¿ IVD¿ Erythropoietin Human Serum Controls are prepared from pooled human serum and contain natural and recombinant human Erythropoietin.
R & D Systems, Inc. Recall 90445 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1390-2022 |
| Event ID | 90445 |
| Event Description | Quantikine¿ IVD¿ Erythropoietin Human Serum Controls are prepared from pooled human serum and contain natural and recombinant human Erythropoietin. |
| Product Type | Devices |
| 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. |
| Quantity | 400 |
| Recall Reason | The reason for recall of this device is that 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 |
| Device Classification | 20220727 |
| Device Code Info | Lot Code: UDI 00815762021671, Lot Codes: P301801; P304262; P306132; P310038; P314685; P320216; P322531 Expiration Date: 08/04/2023 |
| Center Classification Date | 20220715 |
| Recall Initiation Date | 20220614 |
| Recalling Firm | R & D Systems, Inc. |
| Initial Notification | |
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