AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics
FDA Recall Z-0734-2007 · Posted 2007-04-11
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Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeNTI
Date Initiated2007-03-09
Date Terminated2007-08-23
Product Quantity129
Reason for Recall
The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I rec., RNase-free, P/N 04716728001 (Roche Applied Science)" . The Part Number listed for the DNase I listed is incorrect and of lower specific activity than the correct/validated DNase.
Firm Action
A product advisory notice was issued on March 9, 2007 to all affiliates, indentifying the problem and listing corrective actions followed by a customer letter (Urgent Medical Device Correction) issued on 3/21/2007, requesting several actions be performed including discontinued use of incorrect DNAse I.
Root Cause
Other
Distribution Pattern
World wide Distribution --- USA including states of MI, IN, NC, CA KY, IN, VA, and FL.and countries of Netherlands, Germany, Sweden, Denmark, Italy, Spain, Belgium, Switzerland, and Hungary
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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