medical Class II Updated 2024-11-27

Roche Diagnostics Operations, Inc. recalls cobas HCYS, Homocysteine Enzymatic Assay, Material Number RE

Recalled Product

cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine


Hazard / Issue

Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)

Issued by

FDA

Affected States: NJ, TX, NY, FL, IN, OK, SC, IA
Lot/Code Info: UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
View official government recall

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