i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park… recallZ-0812-2010 · Abbott Point of Care Inc. · initiated Sep 9, 2009
Terminated All recalls posted in February 2010
Is my device affected?
- 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.
- 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.
- 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
The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.
FDA root cause category: Labeling mix-ups
What the company is doing
An "Urgent Recall Notice" was issued to customers during September 2009. The letter described the affected product, issue and recommended actions. Customers were asked to verify storage conditions on the box are correct and if not, discard the outside box. If the customer requires a replacement box, the customer must contact Abbott Point of Care Technical Support. Direct questions and requests for additional information to the Abbott Point of Care Technical Support by calling 1-800-366-8020, Option 1 or contact your Abbott Point of Care representative.
Recall details
- Recall number
- Z-0812-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 9, 2009
- Posted by the FDA
- Feb 24, 2010
- Recalling firm
- Abbott Point of Care Inc.
- Quantity
- 3,918 analyzers
- Product code
- CGA
- FDA submissions
- K001387
- Distribution
- Worldwide Distribution (including the United States).
Product description
i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels.
Code information (models, lots, serial numbers)
Catalog number 06F16-10.
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.
- i-STAT 04P75-31Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE5 reports
- i-STAT 04P75-32Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE4 reports
- i-STAT 04P75-30Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE3 reports
- i-STAT 04P75-35Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE1 report
- i-STAT 04P75-36Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE1 report
- i-STAT 04P75-38Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE1 report
- i-STAT 04P75-44Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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