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Terminated

Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.

FDA Recall Z-0538-05 · Posted 2005-02-15

Recalling FirmDade Behring , Inc.
Recall StatusTerminated
Product CodeDAP
Date Initiated2004-12-03
Date Terminated2005-10-18
Product Quantity25381 units

Reason for Recall

decrease in product stability after reconstitution and reduced stability on board certain instrument systems

Firm Action

The recalling firm issued a recall letter to their customers informing them of the problem and the need to use internal quality controls with the analyzers. The letter instructed customer to discard lot # 544545 and reduce the stability for the other lot numbers involved.

Root Cause

Other

Distribution Pattern

The product was shipped nationwide to medical facilities.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041438ADVANCED D-DIMER ASSAYDade Behring, Inc. · 2004-08-11

Official Source

View FDA Recall →

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

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