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U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3274-2026%22

Class II recall Z-3274-2026: Alere San Diego, Inc.

Q: How to monitor Class II recall Z-3274-2026: Alere San Diego, 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-3274-2026: Alere San Diego, Inc. (California): Alere San Diego, Inc. Dated 29 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-3274-2026
Recalling firm	Alere San Diego, Inc.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073; Alere hCG Cassette (25mIU/mL) in Urine, Model/ Part: FHC-102/92217; Cardinal Health hCG Cassette Rapid test CLIA Waived, Model/ Part: FHC-102/B1077-22; Medline HCG Pregnancy Test Cassette, Model/ Part: FHC-102/MPH12025HCG; Pro Advantage By NDC Urine Pregnancy Cassette Device, Model/ Part: FHC-102/P080063;
Reason	hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Quantity	18,139,960
Distribution	Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Irel
Recall initiated	2026-08-20
Reported	2026-10-07
Firm location	San Diego, CA, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-07
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 21:30:53 GMT

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Peer benchmark and outreach value: Class II recall Z-3274-2026: Alere San Diego, 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 29 days ago.

What is the FDAPulse record for Class II recall Z-3274-2026: Alere San Diego, Inc. in California?

Class II device recall Z-3274-2026 by Alere San Diego, Inc.: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive resu

How does Class II recall Z-3274-2026: Alere San Diego, Inc. compare to other California FDAPulse records?

It is 29 days old, still within a typical 45-day follow-up window.

Class II recall Z-3274-2026 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-3274-2026	CA	2026-10-07
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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