Z-1028-2013 Class II Terminated
FDA device recall Z-1028-2013 was initiated by Roche Diagnostics Operations, Inc. on Mar 1, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jun 4, 2014). Affected quantity: 189 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 10, 2013
- Initiation Date
- Mar 1, 2013
- Termination Date
- Jun 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 189 units
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.
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.
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.
Code Information
Lot / SN : 477415,477416, 477898, and 477899
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1028-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026