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Terminated

Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle); Product is distributed by Abbott Hematology, 5440 Patrick Henry Dr., Santa Clara, CA 95054

FDA Recall Z-0269-06 · Posted 2005-12-06

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGKZ
Date Initiated2005-09-20
Date Terminated2006-11-02

Reason for Recall

The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results.

Firm Action

On September 20, 2005, the firm issued letters to all its direct consignees, informing them of the affected product and providing instructions on the recall. In February, the firm expanded its recall to all lots as a result of having identified an additional failure in a different lot.

Root Cause

Other

Distribution Pattern

Distribution of DILUENT is worldwide to a total of 1,584 consignees. All CELL-DYN 1800 customers were notified via the Device Recall Letter. At the time of receipt of the letter, the customer may or may not have the recalled lots in their inventory. Therefore, the letter directed the customer to assess their inventory of DILUENT 08H17-01 and 99226-01 to determine if they had any of the affected lots in their possession. Foreign countries include: Canada, Columbia, Uruguay, Germany, Barbados, Bermuda, Cayman Islands.

Official Source

View FDA Recall →

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

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