Dade Behring Inc. Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic.
Brand
Dade Behring Inc.
Lot Codes / Batch Numbers
Lot #446003002 and 446058002.
Products Sold
Lot #446003002 and 446058002.
Dade Behring Inc. is recalling Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic. due to Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.
Recommended Action
Per FDA guidance
Customers were provided clear written instructions (04/06/2006) to discontinue use and discard remaining inventory of products over 2 months old. In addition, each customer is being contacted by phone as an effectiveness verification. Recalling firm is also instructing Stratus CS customers to process all samples and dilutions in duplicate.
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 noticePage updated: Jan 10, 2026