DATE WITHDRAWAL INITIATED:
PRODUCT / LOT NUMBERS:
HIV-1 / HCV Assay, Procleix
Lot Number: 401254
1000 Test Kit - Part Number 301031
5000 Test Kit - Part Number 301030
MANUFACTURER:
Gen-Probe Inc
San Diego, CA
DISTRIBUTOR:
Chiron Corp
Emeryville, CA
REASON:
Procleix HIV-1 / HCV Assay, Master Lot 401254, was found to contain an elevated level of copper. The source of the elevated copper was the raw material, Trehalose, which is also a component of the Enzyme Reagent. The increase in copper may affect kit performance.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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