Abbott Point Of Care Inc. — FDA Enforcement History

FDA action counts

Enforcement history

On 2026-05-06, Argus HQ recorded a FDA recall for Abbott Point Of Care Inc., rated "high" severity in Argus HQ's classification: Abbott Point Of Care Inc. — Class II recall: i-STAT G3+ cartridge; List Number: 03P78-26; An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Abbott Point Of Care Inc., rated "high" severity in Argus HQ's classification: Abbott Point Of Care Inc. — Class II recall: i-STAT EG7+ cartridge; List Number: 03P76-25; An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Abbott Point Of Care Inc., rated "high" severity in Argus HQ's classification: Abbott Point Of Care Inc. — Class II recall: i-STAT EG6+ cartridge; List Number: 03P77-25; An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Abbott Point Of Care Inc. has 3 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Abbott Point Of Care Inc. has 3 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

Does Argus HQ track new FDA actions for Abbott Point Of Care Inc. automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Abbott Point Of Care Inc. is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Abbott Point Of Care Inc.?

3 total: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Abbott Point Of Care Inc.?

May 6, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Abbott Point Of Care Inc. had product recalls?

Yes, 3 recalls on file. See the full history below for each one.

Related enforcement actions

• Abbott Point Of Care Inc. — Class II recall: i-STAT EG7+ cartridge; List Number: 03P76-25; →
• Abbott Point Of Care Inc. — Class II recall: i-STAT G3+ cartridge; List Number: 03P78-26; →
• Abbott Point Of Care Inc. — Class II recall: i-STAT EG6+ cartridge; List Number: 03P77-25; →

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