i-STAT BNP cartridge recallZ-0319-2011 · Abbott Point Of Care Inc. · initiated Jan 1, 2008
Terminated All recalls posted in November 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
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0319-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 1, 2008
- Posted by the FDA
- Nov 3, 2010
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 482,500 (total)
- Product code
- CHL
- FDA submissions
- K053597
- Distribution
- Worldwide Distribution: USA and Canada.
Product description
i-STAT BNP cartridge Abbott Point of Care, Princeton, NJ 08540
Code information (models, lots, serial numbers)
06F30-01;06F30-02: This product has various expiration dates. All products have expired.
Other devices under the same FDA submission
1 device cleared under K053597 — 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 03P93-25Abbott Point Of Care Inc. · TEST,NATRIURETIC PEPTIDE2 reports
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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