Roche Diagnostics Corp. Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units.
Products Sold
All units.
Roche Diagnostics Corp. is recalling Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrume due to If the user opens the instrument lid during decontamination, the cycle will stop but the timer will continue resulting in the user believing the instr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
If the user opens the instrument lid during decontamination, the cycle will stop but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not been.
Recommended Action
Per FDA guidance
Consignees were notified via recall letter dated 7/17/06 to restart the sterilization cycle if they open the instrument for any reason during the sterilization cycle.
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