Roche Recalls 78 Cobas 8000 Analyzers Due to Reagent Pipetting Defect
Roche Diagnostics is recalling 78 Cobas 8000 Modular Analyzers because a probe positioning mismatch can cause insufficient reagent pipetting, potentially affecting test results.
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 3/5 (High).
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. The hazard involves potential diagnostic errors due to insufficient reagent pipetting, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 78 units of the Cobas 8000 Modular Analyzer Series, specifically the cobas c 701 and cobas c 702 modules. The recall is due to a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions. This defect can lead to insufficient reagent pipetting, which may affect the recovery of patient samples and controls for specific tests, including Alkaline Phosphatase, Alanine Aminotransferase, Bicarbonate, and Creatinine.
The affected units were distributed nationwide, including in the states of Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Virginia, Washington, and Wisconsin. The recall covers specific catalog numbers for the reagents and a list of serial numbers for the analyzers.
Healthcare facilities and laboratories should stop using the affected Cobas 8000 modules and contact Roche Diagnostics for instructions on how to return or replace the equipment. This recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 78
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)
- Catalog numbers affected: Alkaline Phosphatase acc. to IFCC Gen.2 05166888190
- Bicarbonate Liquid 05446376190
- Creatinine Jaff¿ Gen.2 05168597190
- C-Reactive Protein Gen.3 05172373190
- and Urea/BUN 05171873190. Serial Number(s): 0917-10
- 1020-04
- 1020-05
- 1021-03
- 1021-04
- 1021-07
- 1021-08
- 1023-06
- 1023-09
- 1023-10
- 1024-03
- 1024-04
- 1024-05
- 1024-09
- 1025-02
- 1025-05
Distribution
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