Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.

FDA Recall Z-1305-04 · Posted 2004-07-31

Recalling FirmDade Behring , Inc.
Recall StatusTerminated
Product CodeKFF
Date Initiated2004-06-07
Date Terminated2005-01-06
Product Quantity781 kits

Reason for Recall

Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent.

Firm 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

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑