Recall Z-1305-04 ยท KFF Assay, Heparin
Dade Behring , Inc.
Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
| Date | Jul 31, 2004 (initiated Jun 7, 2004) |
| Status | Terminated |
| Reason | Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent. |
| Root cause | Other |
| Action | 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 |
| Quantity | 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, WI, WV. Further, there are foreign countries also affected in this recall action, as listed: Aus |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.