Roche Diagnostics Corp. MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All systems using software version 3.09.
Products Sold
All systems using software version 3.09.
Roche Diagnostics Corp. is recalling MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. due to Test results may be adversely affected by software shutting down the cooling blocks in systems with software version 3.09.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Test results may be adversely affected by software shutting down the cooling blocks in systems with software version 3.09.
Recommended Action
Per FDA guidance
Consignees were notified via letter dated 11/5/04, which provides the user with a workaround.
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