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Recall Observatory FDA recall evidence

Device product

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.

Z-1028-2013

March 01, 2013

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 64453
Status
Terminated
Classification
Class II
Quantity
189 units
Official record key
device-enforcement:Z-1028-2013

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.