i-STAT EC4+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red bloo

FDA device recall Z-1797-2010 · posted 2010-06-11 · Terminated

Recall details

Recalling firm

Abbott Point of Care Inc.

Reason for recall

Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.

Action taken

The firm, Abbott Point of Care, sent an "Urgent Field Safety Notice Product Recall" letter dated January 2010 to the customers. Safety Alert /Product Recall letters were also sent by Federal Express commencing on February 5, 2010. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to replace the i-STAT Hematocrit/HCT and Calculated Hemoglobin/HB /Cartridge and Test Information (CT) Sheet found in their i-STAT System manual with those included in the mailing , and to provide a copy of the letter another facility, if they have forwarded any cartridges. If you should have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020 or your Abbott Point of Care representative.

Root cause

Other

Status

Terminated

Product code

JPI

Quantity affected

40,446 total cartridges, all varieties

Distribution

Worldwide distribution: USA and Argentina; Austria; Bahamas; Bolivia; Brazil; Chile; Hong Kong; China; China; Columbia; Costa Rica; Denmark; Dominican Republic; Ecuador; El Salvador; Finland; Georgia;

Date initiated

2010-02-05

Date posted

2010-06-11

Date terminated

2012-07-25

Location

Princeton, NJ

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