Z-0269-06

Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08H17-01,(on box)...

Name: Z-0269-06 Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08H17-01,(on box)...
Creator: Abbott Laboratories
Published: 2005-09-20
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-09-20 / Terminated

FDA source

Abbott Laboratories began a recall of 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... on 2005-09-20. The reason FDA records is "The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0269-06
Status: Terminated
Initiated: 2005-09-20
Posted: 2005-12-06
Terminated: 2006-11-02
Recalling firm: Abbott Medical
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
Product code: GKZ Counter, Differential Cell
Reason for recall: The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results.
FDA root cause: Other
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.
Distribution: 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.
Product codes and lots: (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.

Product code GKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)