Roche Diagnostics Corp. Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R . Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R .
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units.
Products Sold
All units.
Roche Diagnostics Corp. is recalling Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R . due to The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Recommended Action
Per FDA guidance
A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026