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Terminated

TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).

FDA Recall Z-0983-05 · Posted 2005-07-13

Recalling FirmRoche Molecular Systems Inc
Recall StatusTerminated
Product CodeMVU
Date Initiated2005-02-14
Date Terminated2006-10-03
Product Quantity450 sets

Reason for Recall

Low level of recombinant HIV DNA found in one lot of HBV QS which is a component of one lot of the TaqMan HBV ASR.

Firm Action

Notification letter to LabCorp wa sent on 2/14/2005 via FedEx.

Root Cause

Other

Distribution Pattern

One customers received 14 kits on 1/3/2005. This one customer was LabCorp, 1912 Alexander Drive, Research Triangle Park, NC 27709.

Official Source

View FDA Recall →

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

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