FDA Device recall Z-1390-2022
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations…
- FDA Device
- Class III
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class III recall of Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations… by R And D Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1390-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-06-14 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | R And D Systems |
| Distribution | US |
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
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 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
Identifiers
| code_info | Lot Code: UDI 00815762021671, Lot Codes: P301801; P304262; P306132; P310038; P314685; P320216; P322531 Expiration Date: 08/04/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1390-2022%22
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