R & D Systems, Inc. recalls Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations…
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…
Read the official notice →- Date
- 2022-07-27
- Country
- United States
- Brand
- R & D Systems
- Product
- Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations…
- Classification
- Class III
- Units
- Worldwide distribution - US Nationwide distribution in the states of FL, MN,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More R & D Systems recalls
- 2023-01-25
USR & D Systems, Inc. recalls R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK…
For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
FDA · DeviceR & D Systems, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, FL,…Official notice →
Other drugs & medical recalls in the United States
- 2022-07-27
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Synapse Biomedical Inc recalls NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm…
Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport…
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Boston Scientific Corporation recalls GreenLight HPSEA Laser Fibers, UPN 0010-2092
Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and…
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Aesculap Implant Systems LLC recalls ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic…
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
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GE Healthcare, LLC recalls GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number…
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
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Hobbs Medical, Inc. recalls Hobbs Medical Polypectomy Snare, Catalog No. 7202
During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.
FDA · DeviceHobbs Medical, Inc.Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.Official notice → - US
SONEX HEALTH LLC recalls SX-One MicroKnife
Potential of dull blade
FDA · DeviceSONEX HEALTH LLCUS Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN,…Official notice →