The Recall Desk
ModerateFDA (Devices)·Z-1028-2013·Announced 2013-04-10

Roche cobas x 480 Reagent Reservoirs Recalled for Pipetting Errors

Roche Diagnostics is recalling certain lots of cobas x 480 reagent reservoirs because a missing separation may cause pipetting errors, leading to delayed results and wasted reagent.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the consequences are limited to delayed results and wasted reagent, with no mention of patient injury or illness, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 189 units of Roche Molecular Systems cobas x 480 System 50 mL reagent reservoirs, Catalog number 05232732001. These products are used with the cobas CT/NG 4800 System for in vitro diagnostics. The recall affects lots 477415, 477416, 477898, and 477899.

The recall was initiated because certain lots of the reagent reservoirs may not have a separation in the lower part of the reservoir. This defect can result in an uneven distribution of reagent, which may cause pipetting errors. These errors can lead to delayed diagnostic results and the wasting of reagent.

The affected products were distributed nationwide, 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. Users should check their inventory for the specific catalog and lot numbers listed and contact Roche Diagnostics for further instructions.

The recalled product

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.
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
189

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Related recalls

Same manufacturer · Roche Diagnostics Operations, Inc.

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