QUIDELORTHO recalls VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free…
Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact…
Read the official notice →- Date
- 2024-05-22
- Country
- United States
- Brand
- Quidelortho
- Product
- VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Quidelortho recalls
- 2024-05-22
USQUIDELORTHO recalls VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human…
T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact…
FDA · DeviceQUIDELORTHOWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →
Other drugs & medical recalls in the United States
- 2024-05-22
- US
Fresenius Medical Care Holdings, Inc. recalls Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/…
Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during…
- US
Medartis Inc. recalls APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Screw is 16mm long instead of 22mm long.
FDA · DeviceMedartis Inc.Worldwide - US Nationwide distribution in the state of TX and the countries of…Official notice → - US
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be…
FDA · DeviceHeartSine Technologies LtdUS Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA,…Official notice → - US
QUIDELORTHO recalls VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human…
T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact…
FDA · DeviceQUIDELORTHOWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Baxter Healthcare Corporation recalls Spectrum IQ Infusion pump, Product Code 357009
There is a potential for cracks on the mount of the front panel of the device.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of Ohio, Wisconsin.Official notice → - US
Karl Storz Endoscopy recalls LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then…
FDA · DeviceKarl Storz EndoscopyWorldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX,…Official notice →