Class I - Dangerous
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
LINQ II Insertable Cardiac Monitor
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
Devices may lose functionality due to susceptibility to moisture ingress.
Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
Bard Peripheral Vascular
Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Class I - Dangerous
Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.
Class I - Dangerous
individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result
Class I - Dangerous
Kits were labeled with incorrect expiration dates.
Class I - Dangerous
A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Lusys Laboratories
Class I - Dangerous
COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Class I - Dangerous
There are lower than expected MICs for some gram negative species.
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
Lusys Laboratories
Class I - Dangerous
COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
Lusys Laboratories
Class I - Dangerous
COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Class I - Dangerous
The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.
Class I - Dangerous
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.
meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
The product was incorrectly shipped at room temperature rather than refrigerated.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.