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-0159-2027%22

Class II recall Z-0159-2027: Microgenics Corporation

Q: How to monitor Class II recall Z-0159-2027: Microgenics Corporation and peer other records

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Class II recall Z-0159-2027: Microgenics Corporation (California): Microgenics Corporation. Dated 15 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-0159-2027
Recalling firm	Microgenics Corporation
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP
Reason	Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.
Quantity	1366
Distribution	Worldwide - US Nationwide distribution in the states of UT, MI, OK, NY, TX, CA, LA, SC, OH, MO, OR and the countries of KOR, BGD, THA, ZAF, DEU, VNM, BRA, NZL.
Recall initiated	2026-08-17
Reported	2026-10-21
Firm location	Fremont, CA, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-21
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-0159-2027: Microgenics Corporation 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 15 days ago.

What is the FDAPulse record for Class II recall Z-0159-2027: Microgenics Corporation in California?

Class II device recall Z-0159-2027 by Microgenics Corporation: Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A

How does Class II recall Z-0159-2027: Microgenics Corporation compare to other California FDAPulse records?

It is 15 days old, still within a typical 45-day follow-up window.

Class II recall Z-0159-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0159-2027	CA	2026-10-21
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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