Exact FDA event identifier

Event 80932

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: August 01, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Instrumentation Laboratory Co.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

Z-0077-2019

Recall number: Z-0077-2019
Initiated: August 01, 2018
Classification: Class II
Status: Terminated
Recalling firm: Instrumentation Laboratory Co.
Quantity: 9751 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is a potential for increased imprecision, out of range quality controls and prolonged sample results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for increased imprecision, out of range quality controls and prolonged sample results.

Code information

Lot Number - N0278177 Exp. Date February 28, 2019

Distribution pattern

US Nationwide