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Terminated

Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E

FDA Recall Z-1040-05 · Posted 2005-07-22

Recalling FirmDade Behring , Inc.
Recall StatusTerminated
Product CodeGHH
Date Initiated2005-06-21
Date Terminated2006-05-01
Product Quantity364 kits

Reason for Recall

positive control shows weak agglutination reaction

Firm Action

The recalling firm notified their customers on 6/21/05 via letter dated 6/17/05. The customers were instructed to discontinue the use of the affected lot and discard any remaining inventory.

Root Cause

Other

Distribution Pattern

The product was shipped to hospital laboratories nationwide. The product was also shipped to Hungary, Switzerland, Poland, Spain, Italy, Argentina, Columbia, Mexico, Panama, Phillipines, El Salvadore, and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K872360DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SETAmerican Dade · 1987-07-06

Official Source

View FDA Recall →

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

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