Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
FDA device recall Z-1305-04 · posted 2004-07-31 · Terminated
Recall details
- Recalling firm
- Dade Behring , Inc.
- Reason for recall
- Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent.
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- KFF
- Quantity affected
- 781 kits
- 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, W
- Date initiated
- 2004-06-07
- Date posted
- 2004-07-31
- Date terminated
- 2005-01-06
- Location
- Newark, DE
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