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Terminated

BC Thrombin Reagent . Thrombin Time Test

FDA Recall Z-0007-05 · Posted 2004-10-05

Recalling FirmDade Behring , Inc.
Recall StatusTerminated
Product CodeGJA
Date Initiated2004-07-21
Date Terminated2004-12-15
Product Quantity3942 kits

Reason for Recall

The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin

Firm Action

The recalling firm issued a recall letter dated 7/21/04 to their accounts informing them of the problem and the need to discard the product.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970645BC THROMBIN REAGENTBehring Diagnostics, Inc. · 1997-05-19

Official Source

View FDA Recall →

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

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