Diagnostic Products Corp IMMULITE 2000 Intact PTH kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMMULITE 2000 Intact PTH kit
Brand
Diagnostic Products Corp
Lot Codes / Batch Numbers
Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp date Oct 31 2004)
Products Sold
Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp date Oct 31 2004)
Diagnostic Products Corp is recalling IMMULITE 2000 Intact PTH kit due to High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, CT, MO, VA, WA, DC
Page updated: Jan 10, 2026