—#42161

Product

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 product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
Affected lot / code info: (List Number On the Box---List Number On the bottle---Lot Number): 99226-01---99229-01---15632I2; 08H17-01---08H17-02---15631I2; 08H17-01---08H17-02---15661I2; 08H17-01---08H17-02---16823I2; 08H17-01---08H17-02---17906I2; 08H17-01---08H17-02---17907I2; 08H17-01---08H17-02---18089I2; 08H17-01---08H17-02---19184I2; 08H17-01---08H17-02---19296I2; 08H17-01---08H17-02---20413I2; 08H17-01---08H17-02---21540I2; 08H17-01---08H17-02---22739I2; 08H17-01---08H17-02---23889I2 Expanded: All lots under recall.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

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.

Timeline

Recall initiated: 2005-09-20
Posted by FDA: 2005-12-06
Terminated: 2006-11-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42161. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.