Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA) Recalled by Roche Diagnostics Operations, Inc. Due to Under certain conditions loose ProCell/CleanCell aspiration tube filters...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diagnostics Operations, Inc. directly.
Affected Products
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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 fluids.
Quantity: 462
Why Was This Recalled?
Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Diagnostics Operations, Inc.
Roche Diagnostics Operations, Inc. has 127 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report