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Terminated

Roche MagNA Pure LC Instrument; Catalog nos. 12236931444, 12236931692 ( Refurbished) and 12236931690 (Return). An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.

FDA Recall Z-1374-06 · Posted 2006-08-05

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeNPQ
Date Initiated2006-07-17
Date Terminated2007-12-04
Product Quantity771 total for recalls Z-1372-1374-06

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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