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i-STAT1 Abaxis Analyzer recallZ-1976-2012 · Abbott Point Of Care Inc. · initiated Sep 8, 2011

Class II Terminated All recalls posted in July 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Point Of Care Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1976-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 8, 2011
Posted by the FDA
Jul 9, 2012
Recalling firm
Abbott Point Of Care Inc.
Quantity
6000-0000-650 units
Product code
CHL
FDA submissions
K001387
Distribution
Worldwide Distribution - USA (nationwide)

Product description

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

Code information (models, lots, serial numbers)

i-Stat1 Abaxis Analyzer  6000-0000  All lots

Other devices under the same FDA submission

7 devices cleared under K001387 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 62319).

Sources and updates

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