Devices

Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction. An in vitro diagnostic medical device (IVD).

Model / Serial
Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction. An in vitro diagnostic medical device (IVD).Products Affected: CKMBL, Creatine Kinase-MB, GLDH3, Gen. 3, NH3 Unisys, Ammonia, NH3L, AmmoniaMaterial Numbers: 04525299190, 11929992216, 11877984216, 20766682322, 05975581190Instruments Affected: COBAS INTEGRA, cobas c 501/502, MODULAR P, cobas c 701/702ARTG Number: 174906
Manufacturer
Roche Diagnostics Australia Pty Limited
1 Event
- Recall of Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction. An in vitro diagnostic medical device (IVD).

Manufacturer

Roche Diagnostics Australia Pty Limited

Manufacturer Parent Company (2017)
Roche Holding AG
Source
DHTGA

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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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