Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
This recall has been terminated (originally issued July 31, 2004).
- Recall Initiated
- June 7, 2004
- Posted
- July 31, 2004
- Terminated
- January 6, 2005
- Recall Number
- Z-1305-04
- Quantity
- 781 kits
- Firm Location
- Newark, DE
- Official Source
- View on FDA website ↗
Reason for Recall
Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent.
Distribution
The heparin reagent, which is a component of a test kit, wasdistributed to direct accounts in the following states: AZ, CA, CO, FL, IA, IL, IN, KY, OH, MA, MD, MI, MN, NC, NE, NJ, NM, NY, PA,TN, TX, WI, WV. Further, there are foreign countries also affected in this recall action, as listed: Australia, Canada, France, Finland, Germany, Israel, Italy, Spain, United kingdom, Spain
Lot / Code Info
Lots 541428, 541429, expiration date of Nov 2006
Root Cause
Other
Action Taken
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