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i-STAT G3+ Cartridge recallZ-1306-2014 · Abbott Point Of Care Inc. · initiated Jan 1, 2014

Class II Terminated All recalls posted in March 2014

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

Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.

FDA root cause category: Process control

What the company is doing

APOC sent an Urgent Recall Notice dated January 2014 via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product and provide a copy of this letter to any institution that was forwarded the affected product. All unused cartridges will be credited and are to be returned as instructed on the enclosed Business Reply Card. To ensure continuity of supply at their facility, customers were instructed to follow their standard process to place an order or call Customer Sedrvice at 1-800-323-9100, Option #2, then Option #9). Customers with questions were instructed to contact Abbott Point of Care Technical Support at 1-800-366-8020, Option 1 of their Abbott Point of Care representative. For questions regarding this recall call 800-323-9100.

Recall details

Recall number
Z-1306-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 1, 2014
Posted by the FDA
Mar 27, 2014
Recalling firm
Abbott Point Of Care Inc.
Quantity
48, 450 US, 1400 OUS (49,850 catridges)
Product code
CHL
FDA submissions
K940918
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Canada.

Product description

i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.

Code information (models, lots, serial numbers)

List number 03P78-25 :Lot number N13183

Other devices under the same FDA submission

5 devices cleared under K940918 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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