Devices

Device Recall AccuChek

Model / Serial
Lots 2J081UF, 2J066UF, 2K032UF, 2K050UF, 2K057UF, 2L009UF, 2L079UF, 3A002UF, 3A028UF, 3B011UF, 3C047UF, 3D139UF, 3F074UF, 3F084UF, 3F117UF, 3G025UF, 3G039UF, 3G064UF, 3G084UF, 3G151UF, 3H026UF, 3H034UF, 3H058UF, 3I117UF, 3J048UF, 3K001UF, 3K084UF, 3L079UF, 4A107UF, 4A116UF, 4C133UF, 4C153UF, 4C156UF, 4D133UF, 4E118UF, 4F005UF, 4F135UF, 4F180UF, 4G159UF, 4H066UF, 4H149UF, 4I048UF, 4J004UF, 4J148UF, 4K065UF, 4L079UF, 5B005UF, 5C191UF, 5E070UF, 5F148UF, 5G187UF, 5I092UF, 5I204UF, 5J195UF, 5K027UF, 5L005UF and 6B078UF..
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Product Description
Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and Canada) and Ref No. 04626478001 (Distributed outside the U.S. only).
Manufacturer
Disetronic Medical Systems, Inc.
1 Event
- Recall of Device Recall AccuChek

Manufacturer

Disetronic Medical Systems, Inc.

Manufacturer Address
Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
Source
USFDA

73 devices with a similar name

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Device Recall AccuChek Aviva Plus Test Strip

Model / Serial
Lots 496947, 497291, 497296, 497325
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Honduras Hong Kong (SAR China) Hungary India Indonesia Israel Italy Jamaica Japan Jordan Ireland Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"
Product Description
Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 || Product Usage: || The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
Manufacturer
Roche Diabetes Care, Inc.

Device Recall AccuChek Aviva Plus Test Strip

Model / Serial
Lot 476605
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Honduras Hong Kong (SAR China) Hungary India Indonesia Israel Italy Jamaica Japan Jordan Ireland Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"
Product Description
Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 || Product Usage: || The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.
Manufacturer
Roche Diabetes Care, Inc.

Device Recall AccuChek Aviva Plus Test Strip

Model / Serial
Lot 476340
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Honduras Hong Kong (SAR China) Hungary India Indonesia Israel Italy Jamaica Japan Jordan Ireland Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"
Product Description
Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 || Product Usage: || The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
Manufacturer
Roche Diabetes Care, Inc.

Device Recall AccuChek Go

Model / Serial
All units.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter.
Manufacturer
Roche Diagnostics Corp.

Device Recall AccuChek Aviva

Model / Serial
For the quantitative measurement of the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
Product Description
Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed within the U.S.)
Manufacturer
Roche Diagnostics Corp.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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