Z-2115-2020Class II

Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270...

Name: Z-2115-2020 Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270...
Creator: Inpeco S.A.
Published: 2020-04-07
License: https://open.fda.gov/license/

Inpeco S.p.A. / initiated 2020-04-07 / Terminated / root cause: design

FDA source

Inpeco S.A. began a recall of Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module... on 2020-04-07. FDA classified it as Class II and gives the reason as "The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design". 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-2115-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-07
Posted: 2020-05-26
Terminated: 2024-06-13
Recalling firm: Inpeco S.p.A.
Product: Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.
Root cause tag: design
FDA root cause: Component design/selection
Action: Urgent: Medical Device Correction notification letters dated 3/30/20 were sent to customers. Action to be taken by the user After module protection removal, wait at least 2 seconds before accessing the impacted module (listed in Table 1). Your service provider will contact you to replace the sensor. Until the service visit please maintain awareness on this notice. Please complete and return the "Customer Letter Receipt Confirmation and Implementation Check form" attached to this letter within 15 days directly to the email address specified in the email communication. Please transfer this notice to whom it might concern. Contact reference person: For any clarification you may need, do not hesitate to contact: Eva Balzarotti - Regulatory Affairs Manager E-mail: [email protected] Phone: (+41) 919118 224
Quantity in commerce: 2 systems
Distribution: The products were distributed to the following US States: IL and NY.
Product codes and lots: Serial Numbers: ACP.050 ACP.146

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2115-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2114-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26
Z-2115-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)