Devices

Device Recall Enzymatic assay for the determination of Acetaminophen

Model / Serial
Lot codes: 11021500 7/31/2016 12361201 5/31/2017 11031700 9/30/2018 15247301 8/31/2017 11071400 1/31/2016 18036001 11/30/2017 11071600 8/10/2016 19329601 1/31/2018 11101500 1/21/2016 20511301 5/31/2018 11111600 4/30/2018 24076801 8/31/2018 60482201 2/29/2016 60852601 5/31/2016 61385701 9/30/2016 62032101 1/31/2017
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Roche Acetaminophen assay || 03255379160-HAcetaminophen (P) || 20767174160- cobas c Integra AAcetaminophen150 test
Manufacturer
Roche Diagnostics Corporation
1 Event
- Recall of Device Recall Enzymatic assay for the determination of Acetaminophen

Manufacturer

Roche Diagnostics Corporation

Manufacturer Address
Roche Diagnostics Corporation, 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

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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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