Health product recall

i-STAT hs-TnI Cartridge

Last updated

Summary

Product
i-STAT hs-TnI Cartridge
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

i-STAT hs-TnI Cartridge

B26XXX

09P81-25

i-STAT hs-TnI Cartridge

C26XXX

09P81-25

i-STAT hs-TnI Cartridge

A24XXX

09P81-25

i-STAT hs-TnI Cartridge

B25XXX

09P81-25

i-STAT hs-TnI Cartridge

A25XXX

09P81-25

i-STAT hs-TnI Cartridge

D26XXX

09P81-25

Issue

Abbott has identified that lots beginning with A24, A25, B25, B26, C26, and D26 may have a reduced ability to mitigate certain forms of analytical interference, including macrotroponin and heterophile antibody-related interference, due to variability associated with the alkaline phosphatase component used during reagent manufacturing.  This issue may result in falsely elevated cardiac troponin I results.  There is no evidence that the issue has caused falsely low results.
 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Abbott Point Of Care Inc.

400 College Road E., Princeton, New Jersey, United States, 08540

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82840

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