Z-1798-2018Class II

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

Name: Z-1798-2018 FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Creator: Inpeco S.A.
Published: 2018-02-13
License: https://open.fda.gov/license/

Inpeco S.p.A. / initiated 2018-02-13 / Terminated / root cause: design

FDA source

Inpeco S.A. began a recall of FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System on 2018-02-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1798-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-13
Posted: 2018-05-10
Terminated: 2019-04-03
Recalling firm: Inpeco S.p.A.
Product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 2/13/18, distributors were notified by emailed Technical Service Bulletin. The recalling firm also released a Customer Letter to be forwarded to final customers (labs) by distributors. The Customer Letter advised users of the issue and informed that the recalling firm would be visiting sites to upgrade the firmware to resolve the issue. All impacted customers were instructed to complete and return the Receipt Confirmation within 7 days. Contact provided: Giorgia Amabile - Quality Assurance & Regulatory Affairs Manager, [email protected], (+41) 91 9118 258.
Quantity in commerce: 18
Distribution: Distributors in 2 states: NY and IL.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1798-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1798-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10

Product code JQP

K121012Class IIFlexlab 3.6, Accelerator A3600Inpeco S.P.A. / cleared 2012-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)