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Terminated

Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test

FDA Recall Z-1374-05 · Posted 2005-08-16

Recalling FirmDade Behring , Inc.
Recall StatusTerminated
Product CodeGJT
Date Initiated2005-07-08
Date Terminated2006-08-10
Product Quantity3255 packs

Reason for Recall

sample may exhibit falsely high results

Firm Action

On 7/13/05, the recalling firm issued letters to their customers informing them of the problem and the need to discontinue use and to discard any remaining product.

Root Cause

Other

Distribution Pattern

The product was shipped to medical facilities and laboratories in AR, AZ, CA, FL, GA, ID, IL, IN, KS, KY, MA, MD, NC, ND, NV, NY, OH, OK, PA, TX, VA, WA, WI, and WV. The products were also shipped to Germany, Belgium, Switzerland, Sweden, Netherlands, Russia, Spain, France, Italy, Portugal, Australia, Chile, China, Saudi Arabi, Taiwan, and Uraguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K924396CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMABehring Diagnostics, Inc. · 1993-05-21

Official Source

View FDA Recall →

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

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