FDA Medical Device Recalls (openFDA)
Abbott Point Of Care Inc.: i-STAT BNP cartridge Abbott Point of Care, Princeton, NJ 08540
- Recall number
- Z-0319-2011
- Recalling firm
- Abbott Point Of Care Inc.
- Product
- i-STAT BNP cartridge Abbott Point of Care, Princeton, NJ 08540
- Status
- Terminated
- Initiated
- 2008-01-01
- Posted
- 2010-11-03
- Terminated
- 2011-09-14
- Reason
- i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.
- Root cause
- Other
- Action
- Abbott Point Of Care Inc.sent notification letters with a customer reply form to all affected customer in January, 2008. All distributors outside the US who were sent shipments from the affected lots were notified of the lot numbers that were affected. Affected product is to be quarantined and returned for replacement. Customers with questions about this recall can contact Abbott Point Of Care at 609 454-9000.
- Quantity
- 482,500 (total)
- Distribution
- Worldwide Distribution: USA and Canada.
- Lot, serial or model codes
- 06F30-01;06F30-02: This product has various expiration dates. All products have expired.
- 510(k) numbers
- ["K053597"]
- PMA numbers
- not on file
- Product code
- CHL
- 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