Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoie
FDA device recall Z-1390-2022 · posted 2022-07-15 · Completed
Recall details
- Recalling firm
- R & D Systems, Inc.
- 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
- Action taken
- 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.
- Root cause
- Process control
- Status
- Completed
- Product code
- GGT
- Quantity affected
- 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,
- Date initiated
- 2022-06-14
- Date posted
- 2022-07-15
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS (K931756) | R&D Systems, Inc. | 1994-04-21 |