The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1791-2014·Announced 2014-06-25

Roche cobas 6000 Analyzer Filters Recalled for Potential Aspiration Issues

Roche Diagnostics is recalling cobas 6000 analyzer filters that may cause discrepant results and system alarms.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity recall involving a potential device malfunction.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 1,147 units of cobas 6000 analyzer series filters (Material No. 03149773001) distributed nationwide in the United States. The recall is due to a defect where loose ProCell/CleanCell aspiration tube filters may cause consecutive discrepant results, sipper alarms, and foam on reservoirs and system reagent alarms.

This recall affects laboratories using the cobas 6000 analyzer series for in-vitro quantitative and qualitative determination of analytes in body fluids. The source text does not report any illnesses, injuries, or deaths associated with this recall. Users should contact Roche Diagnostics for instructions on how to address the affected filters.

The recalled product

Product
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body…
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — Laboratory Analyzer
Hazard
Affected units
1,147

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 (20)

  • 1848-01
  • 1848-03
  • 1848-04
  • 185503
  • 1845-15
  • 186211
  • 1857-12
  • 186225
  • 1862-16
  • 1862-10
  • 185715
  • 185817
  • 1865-05
  • 1862-27
  • 1858-35
  • 1859-30
  • 1859-33
  • 1863-05
  • 1867-14
  • 1844-16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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