i-STAT HL7 Interface recallZ-0865-2010 · Abbott Point of Care Inc. · initiated Sep 29, 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
Abbott Point of Care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the incorrect patient name, order number of comment being included in the CDS test record only.
FDA root cause category: Software design
What the company is doing
Urgent Recall Notification letters were sent by Fed Ex to all US customers on September 29, 2009 and worldwide on October 1, 2009. Questions should be directed to Abbott Point of Care Technical Support at 1-800-366-8010, Option 1.
Recall details
- Recall number
- Z-0865-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 29, 2009
- Posted by the FDA
- Feb 26, 2010
- Recalling firm
- Abbott Point of Care Inc.
- Quantity
- 36
- Product code
- JQP
- FDA submissions
- K001387
- Distribution
- Nationwide and Foreign: Germany, the United Kingdom, Switzerland and the Netherlands.
Product description
i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
Code information (models, lots, serial numbers)
i-STAT Catalog number: 111610 Abbott list number (US and Canada) 08K4501
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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