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Terminated

DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.

FDA Recall Z-0042-05 · Posted 2004-10-23

Recalling FirmDade Behring , Inc.
Recall StatusTerminated
Product CodeJPA
Date Initiated2004-08-27
Date Terminated2005-05-10
Product Quantity7140 units

Reason for Recall

APTT determinations when using affected rotors may lead to incorrectly shortened times

Firm Action

The recalling firm issued a recall letter dated 8/27/04 to their direct accounts informing them of the problem. The recalling firm also sent instructions for a work around until a solution can be established.

Root Cause

Other

Distribution Pattern

The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011665BCT SYSTEMDade Behring, Inc. · 2001-08-09

Official Source

View FDA Recall →

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

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