Exact FDA event identifier

Event 81160

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

Open FDA event record

Event summary

Timeline bucket: August 10, 2018
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Medtest Holdings, Inc.

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

Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.

Z-0389-2019

Recall number: Z-0389-2019
Initiated: August 10, 2018
Classification: Class III
Status: Terminated
Recalling firm: Medtest Holdings, Inc.
Quantity: 22

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Vials of the autoHDL/LDL Calibrator were shipped without a vial label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Vials of the autoHDL/LDL Calibrator were shipped without a vial label.

Code information

Lot Number 808801-180; UDI: 00811727011411

Distribution pattern

US Nationwide in the states of CA, FL, GA, MI, and OH.