Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Cocaine Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
EDDP Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Methamphetamine Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Methadone Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
THC Test Card; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Clinical Diagnostic Solutions
Class I - Dangerous
Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
Philips Medical Systems
Class I - Dangerous
Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.
Legionella Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics
Class I - Dangerous
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.