Recall Z-1390-2022 ยท GGT Assay, Erythropoietin
R & D Systems, Inc.
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
| Date | Jul 15, 2022 (initiated Jun 14, 2022) |
| Status | Terminated |
| 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. 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 |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931756 | QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS R&D Systems, Inc., Apr 21, 1994 |