The Recall Desk
HighFDA (Devices)·Z-2477-2019·Announced 2019-09-11

Roche Recalls Cobas 8000 Analyzer Modules Due to Valve Quality Issue

Roche Diagnostics is recalling 19 Cobas 8000 Modular Analyzer Series units due to a quality issue with high pressure solenoid valves.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'High' severity score under the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 19 units of the Cobas 8000 Modular Analyzer Series. The affected products include the cobas 8000 ISE module, cobas c 701 module, and cobas c 702 module. The recall is being conducted due to a quality issue with high pressure solenoid valves.

The affected units were distributed to facilities in New York, Montana, Hawaii, Indiana, Maryland, Texas, Ohio, Kansas, Kentucky, California, Florida, Oregon, Louisiana, Missouri, and Alaska. Specific serial numbers for the affected modules are listed in the agency's recall record.

This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Users should contact Roche Diagnostics Operations, Inc. for further instructions regarding the recall.

The recalled product

Product
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — Laboratory Analyzer
Hazard
Affected units
19

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 (17)

  • cobas c 701 module Serial # : 19P2-01
  • 1390-03
  • 1139-04
  • 1139-05
  • 1139-06. cobas c 702 module serial # : 1126-03
  • 1237-10
  • 14C2-04 cobas¿ 8000 ISE module serial # : 1943-01
  • 1943-02
  • 1943-03
  • 1943-04
  • 1943-05
  • 1943-06
  • 1943-07
  • 1943-08
  • 1943-09
  • 1943-10
  • 15B3-05.

Distribution

Distributed in 15 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 →

Related recalls

Same manufacturer · Roche Diagnostics Operations, Inc.

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Same hazard · quality issue

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