Roche Diagnostics Operations, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1622-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.

Product Classification:

Class II

Date Initiated: March 23, 2015

Date Posted: May 27, 2015

Recall Number: Z-1622-2015

Event ID: 71034

Reason for Recall:

Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An elevated level of Homocysteine is considered an important risk factor in the assessment of peripheral vascular disease. Falsely low values could lead to a delay of di

Status: Terminated

Product Quantity: 2558 units

Code Information:

05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA Lot number 69781101

Distribution Pattern:

Nationwide Distribution-including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, , SC, TN, TX, VA, WA, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated