Roche recalls Cobas 8000 Modular Analyzer modules with potential high pressure solenoid valve quality issues. Affected units include specific part and serial numbers listed in the recall notice.
Quality issue with high pressure solenoid valves
Roche is recalling certain Cobas 8000 Modular Analyzer modules due to a quality issue with high pressure solenoid valves. This could lead to malfunction or damage if the valve fails under normal use conditions.
The quality issue with high pressure solenoid valves could cause the valve to malfunction under normal use conditions. This might lead to system failures or damage to the analyzer, potentially affecting laboratory testing accuracy.
Laboratory users who own or operate the Cobas 8000 Modular Analyzer system with the specified part and serial numbers are affected. Healthcare professionals using these modules for laboratory testing are most at risk.
Check for the specific part numbers: 05964075001 (cobas 8000 ISE module), 05641489001 (cobas c 701 module), and 06473245001 (cobas c 702 module). Also look for the listed serial numbers on the modules.
Verify the part numbers and serial numbers of your Cobas 8000 modules against the list provided in the recall notice.
The recall affects Cobas 8000 ISE modules with part number 05964075001, cobas c 701 modules with part number 05641489001, and cobas c 702 modules with part number 06473245001.
Check the serial numbers on your modules: cobas c 701 modules with serial numbers 19P2-01, 1390-03, 1139-04, 1139-05, 1139-06; cobas c 702 modules with serial numbers 1126-03, 1237-10, 14C2-04; and cobas 8000 ISE modules with serial numbers 1943-01 through 1943-10 and 15B3-05.
The recall notice does not specify a remedy or action for affected modules. You should contact Roche Diagnostics Operations, Inc. for further instructions.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2477-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-2477-2019 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
