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Terminated

STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).

FDA Recall Z-0979-2007 · Posted 2007-07-03

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeGJS
Date Initiated2007-03-30
Date Terminated2009-11-30
Product Quantity170 units

Reason for Recall

Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.

Firm Action

Recall notification letters were sent on March 30, 2007 by first class mail. The letter advises customers that lot 061781 of STA-Neoplastine Cl Plus may cause difficulty during the vailidation process of STA-Coag Control ABN control plasmas, and asks that the lot number be discontinued.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K922040NEOPLASTINE CI PLUSAmerican Bioproducts Co. · 1992-06-23

Official Source

View FDA Recall →

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

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