Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08H17-01,(on box), 99226-01, 08H
FDA device recall Z-0269-06 · posted 2005-12-06 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results.
- Action taken
- 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
- Status
- Terminated
- Product code
- GKZ
- 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 m
- Date initiated
- 2005-09-20
- Date posted
- 2005-12-06
- Date terminated
- 2006-11-02
- Location
- Santa Clara, CA
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