Device recall: Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme…
Class II FDA enforcement event 87223. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification for kits returned from the customer and the retained kits.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
R & D Systems, Inc. started this device recall on 20 Jan 2021. The firm address in the FDA record is in Minneapolis, MN. FDA put the recall in Class II. FDA event 87223 has 1 product record. The first FDA enforcement report date is 24 Mar 2021. The record gives the status Terminated, with the termination date 13 Feb 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,
Recalling firm
R & D Systems, Inc., Minneapolis, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1255-2021 | Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia. | 156 kits | Class II | Terminated | 24 Mar 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Nov 2022 | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2 | Device | Class III | 1 |
| 14 Jun 2022 | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoie | Device | Class III | 1 |
| 1 Nov 2018 | Quantikine IVD ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent | Device | Class III | 1 |
| 11 Sep 2018 | R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 | Device | Class III | 1 |
| 24 Aug 2016 | R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTf | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1255-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 87223. https://recallregister.com/fda/ii/87223/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,
- What quantity of product is in FDA event 87223?
- The FDA record gives this quantity:
156 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.