Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0083-2027%22

Class II recall Z-0083-2027: Beckman Coulter Inc.

Q: How to monitor Class II recall Z-0083-2027: Beckman Coulter Inc. and peer other records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow California records like this one.

Class II recall Z-0083-2027: Beckman Coulter Inc. (California): Beckman Coulter Inc. Dated 22 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0083-2027
Recalling firm	Beckman Coulter Inc.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252
Reason	Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and [email protected] in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to sign
Quantity	146 US, 170 OUS
Distribution	Worldwide - US Nationwide distribution.
Recall initiated	2026-09-02
Reported	2026-10-14
Firm location	Brea, CA, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-14
Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: Class II recall Z-0083-2027: Beckman Coulter Inc. and 76 California peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

California FDAPulse records like this one: 76
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

62 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 22 days ago.

What is the FDAPulse record for Class II recall Z-0083-2027: Beckman Coulter Inc. in California?

Class II device recall Z-0083-2027 by Beckman Coulter Inc.: Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Follo

How does Class II recall Z-0083-2027: Beckman Coulter Inc. compare to other California FDAPulse records?

It is 22 days old, still within a typical 45-day follow-up window.

Class II recall Z-0083-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0083-2027	CA	2026-10-14
Class II recall Z-3155-2026	MA	2026-10-07
Class II recall Z-0232-2027		2026-10-28
Class II recall Z-0243-2027		2026-10-28

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