The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.
Class I - Dangerous
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
Abbott Diabetes Care
Class I - Dangerous
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
Siemens Healthcare Diagnostics
Class I - Dangerous
The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Abbott Diabetes Care
Class I - Dangerous
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.
Class I - Dangerous
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Class I - Dangerous
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Class I - Dangerous
Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.
Class I - Dangerous
A software issue could potentially cause the stand and table movements to be blocked.
Class I - Dangerous
A software issue could potentially cause the stand and table movements to be blocked.
Class I - Dangerous
Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.
HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
Philips North America
Class I - Dangerous
Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the device did not have visible external damage or the Ready for Use ( RFU ) indicator on the unit did not immediately indicate a problem. One of these reports involved a death of a patient who could not be resuscitated.
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
The Binding Site Group
Class I - Dangerous
It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.
Class I - Dangerous
A software issue could potentially cause the stand and table movements to be blocked.
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
BioFire Diagnostics
Class I - Dangerous
Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.