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-0205-2027%22

Class II recall Z-0205-2027: TECHNO-PATH MANUFACTURING LTD.

Q: How to monitor Class II recall Z-0205-2027: TECHNO-PATH MANUFACTURING LTD. and peer other records

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Class II recall Z-0205-2027: TECHNO-PATH MANUFACTURING LTD.: TECHNO-PATH MANUFACTURING LTD. Dated 7 days ago, it is inside the fresh trigger window. Score 68/100. 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: 499 related FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0205-2027
Recalling firm	TECHNO-PATH MANUFACTURING LTD.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	Techno-Path Multichem AE Unassayed Level 1 REF:AE621X
Reason	A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.
Quantity	832 units
Distribution	US Nationwide distribution in the state of Massachusetts.
Recall initiated	2026-08-14
Reported	2026-10-28
Firm location	Ballina Tipperary, Ireland
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-28
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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68 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 7 days ago.

What is the FDAPulse record for Class II recall Z-0205-2027: TECHNO-PATH MANUFACTURING LTD.?

Class II device recall Z-0205-2027 by TECHNO-PATH MANUFACTURING LTD.: A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of M

How does Class II recall Z-0205-2027: TECHNO-PATH MANUFACTURING LTD. compare to other FDAPulse records?

It is fresh: dated 7 days ago, inside the window where early outreach matters most.

Class II recall Z-0205-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0205-2027		2026-10-28
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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