IMMULITE 2000 Intact PTH kit
- Company
- Diagnostic Products Corp.
- Recall Initiated
- February 23, 2004
- Posted
- July 20, 2004
- Terminated
- December 2, 2004
- Recall Number
- Z-0724-04
- Quantity
- 2416 kits
- Firm Location
- Los Angeles, CA
Reason for Recall
High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.
Distribution
North America, Central America, South America, Europe, Asia, South Africa, Middle East. Domestic includes: VA Hospital, St. Louis MO VA Medical Center, Denver, CO VA Medical Center, Richmond, VA VA Medical Center, West Haven, CT Walter Reed Army Medical Center, Washington DC
Lot / Code Info
Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp date Oct 31 2004)
Root Cause
Other
Action Taken
Recall was by letter mailed / faxed on February 23, 2004. Users are instructed to remove EDTA plasma samples for consideration for testing and correct instructions in the package insert.
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