FDA Medical Device Recalls (openFDA)
Abbott Point of Care Inc.: i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
- Recall number
- Z-0865-2010
- Recalling firm
- Abbott Point of Care Inc.
- Product
- i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
- Status
- Terminated
- Initiated
- 2009-09-29
- Posted
- 2010-02-26
- Terminated
- 2010-07-01
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 36
- Distribution
- Nationwide and Foreign: Germany, the United Kingdom, Switzerland and the Netherlands.
- Lot, serial or model codes
- i-STAT Catalog number: 111610 Abbott list number (US and Canada) 08K4501
- 510(k) numbers
- ["K001387"]
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 2245578
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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