Roche Diagnostics Corp. MagNA Pure LC Instrument; Catalog number 2236931. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MagNA Pure LC Instrument; Catalog number 2236931.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units with software version 3.0.
Products Sold
All units with software version 3.0.
Roche Diagnostics Corp. is recalling MagNA Pure LC Instrument; Catalog number 2236931. due to Potential for false negative patient results with software version 3.0. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for false negative patient results with software version 3.0
Recommended Action
Per FDA guidance
An Urgent Product Correction letter dated 5/27/03 was sent to each customer.
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 noticeDistribution
As reported by FDA
CA, GA, IL, ME, MI, MS, NY, OH, OR, PA, TX, UT, WI
Page updated: Jan 10, 2026