Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
Randox Laboratories
Class I - Dangerous
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Detect Covid-19 Test Product/Model Number: 21205
Detect Headquarters
Class I - Dangerous
There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Medtronic MiniMed
Class I - Dangerous
An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
DeRoyal Tonsillectomy Tray, REF 89-10698.01
DeRoyal Industries
Class I - Dangerous
DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Beckman Coulter
Class I - Dangerous
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
API VP1 VP2 REAGENTS, CATALOG 70422
Biomerieux
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
API JAMES 2AMP, CATALOG 70542
Biomerieux
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed