CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation recalled

Inpeco is recalling FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation, distributed in Illinois, New York. The recall was initiated on 13 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled18

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1798-2018
FDA event ID: 79645
Recalling firm: Inpeco, Lugano, N/A
Classification: Class II
Status: Terminated
Recall initiated: 13 Feb 2018
FDA classified: 10 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Feb 2018	Recall initiated by company
10 May 2018	Classified by FDA	+86 days
16 May 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Distributors in 2 states: NY and IL.

Illinois New York

Questions about this recall

Is FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation recalled?

Yes. Inpeco recalled FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation on 13 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1798-2018.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Distributors in 2 states: NY and IL.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Inpeco

All 33

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025Device	CLASS II	FlexLab (FLX) recalled by Inpeco	Inpeco	Other	Nationwide
3 Dec 2025Device	CLASS II	FlexLab (FLX) recalled by Inpeco	Inpeco	Other	Nationwide
15 Oct 2025Device	CLASS II	FlexLab (FLX) System recalled by Inpeco	Inpeco	Other	CA, NY
15 Oct 2025Device	CLASS II	FlexLab X (FXX) System recalled by Inpeco	Inpeco	Other	CA, NY
27 Dec 2023Device	CLASS II	Roche Cobas 8000 and Cobas PRO Interface Module recalled by Inpeco	Inpeco	Lead & Heavy Metals	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide