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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott

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 Class 2 Device Recall Abbottsee related information
Date Initiated by FirmSeptember 20, 2005
Date PostedDecember 06, 2005
Recall Status1 Terminated 3 on November 02, 2006
Recall NumberZ-0269-06
Recall Event ID 33616
Product Classification Counter, Differential Cell - Product Code GKZ
ProductAbbott 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
Code Information (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.
FEI Number 2919069
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
Manufacturer Reason
for Recall		The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results.
FDA Determined
Cause 2		Other
ActionOn 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.
DistributionDistribution 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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