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Terminated

HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France

FDA Recall Z-0073-2007 · Posted 2006-10-25

Recalling FirmSebia, Inc.
Recall StatusTerminated
Product CodeJBD
Date Initiated2006-08-29
Date Terminated2010-01-28
Product Quantity71 kits

Reason for Recall

The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.

Firm Action

Consignees were notified via fax letter and also by phone contact on or about 08/29/2006.

Root Cause

Other

Distribution Pattern

Nationwide (AL, CA, CO, FL, GA, IL, KA, LA, MD, MI, NM, NC, NJ, NY, PA, TX, VA, WI) and Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)Morax · 1999-06-21

Official Source

View FDA Recall →

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

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