FDAFDA · Food and drugs·Recall number Z-1028-2013
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.
Published April 10, 2013 · Recall initiated: March 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- 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.
- Lot
- Lot / SN : 477415,477416, 477898, and 477899
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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