Roche Diagnostics Operations, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1028-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, for in vitro diagnostics.

Product Classification:

Class II

Date Initiated: March 1, 2013

Date Posted: April 10, 2013

Recall Number: Z-1028-2013

Event ID: 64453

Reason for Recall:

Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.

Status: Terminated

Product Quantity: 189 units

Code Information:

Lot / SN : 477415,477416, 477898, and 477899

Distribution Pattern:

Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM.

Voluntary or Mandated:

Voluntary: Firm initiated