Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79645

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

Open FDA event record

Event summary

Timeline bucket
February 13, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Inpeco S.A.

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

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System

Z-1798-2018
Recall number
Z-1798-2018
Initiated
February 13, 2018
Classification
Class II
Status
Terminated
Recalling firm
Inpeco S.A.
Quantity
18

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.

Code information

Serial Numbers: Accelerator a3600 - ACP.150 ACP.185 ACP.186 ACP.192 ACP.202 ACP.214 FlexLab - FLX.0165 FLX.0127 FLX.0128 FLX.0133 FLX.0157 FLX.0160 FLX.0181 Aptio Automation - AP2.0054 AP2.0056 AP2.0060 AP2.0078 AP2.0095 Part Numbers of impacted sample tube carriers: 721501001 for 43 mm carriers, and 0A00006957 for 40 mm carriers

Distribution pattern

Distributors in 2 states: NY and IL.

Field note

Send feedback

We'll only use this to respond to your feedback.