Z-1373-06

Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for...

Name: Z-1373-06 Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for...
Creator: Roche Diagnostics Corp.
Published: 2006-07-17
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-07-17 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for isolation and purification of nucleic acids and... on 2006-07-17. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1373-06
Status: Terminated
Initiated: 2006-07-17
Posted: 2006-08-05
Terminated: 2007-12-04
Recalling firm: Roche Diagnostics GmbH
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.
Product code: NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Reason for recall: 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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 771 total for recalls Z-1372-1374-06
Distribution: Nationwide.
Product codes and lots: All units.

Product code NPQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)