Abbott Laboratories Recalls
Showing 81-87 of 87 recalls
14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Removal (list #00226). Single Use Sterile Gastrostomy Kits.
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
The recalling firm notified customers by letter, dated 11/12/04.
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
The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results.
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.
i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.
The firm provided an 'Urgent Letter', acknowledgement form, floppy disks, and labels to all customers who received the celite ACT cartridge.
CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.
The firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system.
Gemstar 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version
Products contain software deficiencies which could allow over infusion thereby administering excess medication.
On 4/1/03, the firm issued letters via Federal Express Overnight Delivery to all its direct consignees, informing them of the affected devices and providing instructions on the recall.