Abbott Point Of Care Inc.: i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

Recall number

Z-1976-2012

Recalling firm

Abbott Point Of Care Inc.

Product

i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

Status

Terminated

Initiated

2011-09-08

Posted

2012-07-09

Terminated

2013-01-28

Reason

Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.

Root cause

Device Design

Action

Abbott Point Care sent an Urgent Product Recall letter dated September 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm the number of affected product at their facility that were using the Old Battery Carrier. Fill out the affected Buesiness Reply Card and submit their facility information as per the instructions on the card. Upon the receipt of the New Battery Carriers, replace the Old Battery Center with the New Battery Center. Customers were instructed to immediately dispose of all Old Battery Carriers per local regulations. If customers forward the affected product to another facility, they should provide a copy of the recall letter to them and advise them to replace the carriers if required. For any questions call 800-366-8020, Option 1 or your Abbott Point of Care representative. For questions regarding this recall call 609-454-9272.

Quantity

6000-0000-650 units

Distribution

Worldwide Distribution - USA (nationwide)

Lot, serial or model codes

i-Stat1 Abaxis Analyzer  6000-0000  All lots

510(k) numbers

["K001387"]

PMA numbers

not on file

Product code

CHL

Firm FEI

2245578

Firm city

Princeton

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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