Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77160

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

Open FDA event record

Event summary

Timeline bucket
April 11, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medica Corporation

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

EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.

Z-1267-2018
Recall number
Z-1267-2018
Initiated
April 11, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medica Corporation
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.

Code information

Medica s Lot # 16292

Distribution pattern

USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.