Dade Behring Inc. Rte 896, Glasgow Business Community Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
Brand
Dade Behring Inc. Rte 896, Glasgow Business Community
Lot Codes / Batch Numbers
Lots 541428, 541429, expiration date of Nov 2006
Products Sold
Lots 541428, 541429, expiration date of Nov 2006
Dade Behring Inc. Rte 896, Glasgow Business Community is recalling Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit. due to Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent.
Recommended Action
Per FDA guidance
The recalling firm sent a recalling letter to the direct accounts informing them that the affected lots can not be used for heparin determinations. Direct account were instructed
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
AZ, CA, CO, FL, IL, IN, IA, KY, MD, MA, MI, MN, NE, NJ, NM, NY, NC, OH, PA, TN, TX, WV, WI
Page updated: Jan 10, 2026