CLASS II ONGOING Device recall · Reported 13 May 2020 · FDA Enforcement Report

Siemens Aptio Automation Centrifuge Module recalled by Inpeco

Inpeco is recalling Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA, distributed in 27 states. The recall was initiated on 7 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: AP2.0001, AP2.0002, AP2.0005, AP2.0008, AP2.0010, AP2.0011, AP2.0012, AP2.0013, AP2.0014, AP2.0016, AP2.0018, AP2.0019, AP2.0023, AP2.0024, AP2.0025, AP2.0026, AP2.0027, AP2.0032, AP2.0033, AP2.0034, AP2.0036, AP2.0039, AP2.0041, AP2.0042, AP2.0044, AP2.0045, AP2.0046, AP2.0047, AP2.0049, AP2.0050, AP2.0051, AP2.0052, AP2.0053, AP2.0054, AP2.0055, AP2.0056, AP2.0057, AP2.0058, AP2.0059, AP2.0060, AP2.0061, AP2.0062, AP2.0063, AP2.0064, AP2.0065, AP2.0067, AP2.0068, AP2.0070, AP2.0071, AP2.0072, AP2.0073, AP2.0074, AP2.0075, AP2.0076, AP2.0077, AP2.0078, AP2.0080, AP2.0081, AP2.0082, AP2.0083, AP2.0084, AP2.0085, AP2.0087, AP2.0088, AP2.0089, AP2.0090, AP2.0091, AP2.0092, AP2.0093, AP2.0094, AP2.0095, AP2.0097, AP2.0098, AP2.0099, AP2.0100, AP2.0101, AP2.0103, AP2.0105, AP2.0106, AP2.0107, AP2.0108, AP2.0109, AP2.0110, AP2.0111, AP2.0112, AP2.0113, AP2.0114, AP2.0115, AP2.0116, AP2.0117, AP2.0118, AP2.0119, AP2.0120, AP2.0121, AP2.0122, AP2.0123, AP2.0124, AP2.0125, AP2.0126, AP2.0127, AP2.0129, AP2.0130, AP2.0132, AP2.0133, AP2.0135, AP2.0136, AP2.0137, AP2.0138, AP2.0140, AP2.0141, AP2.0142, AP2.0143, AP2.0144, AP2.0145, AP2.0146, AP2.0147, AP2.0148, AP2.0149, AP2.0150, AP2.0151, AP2.0153, AP2.0154, AP2.0155, AP2.0156, AP2.0158, AP2.0159, AP2.0160, AP2.0161, AP2.0162, AP2.0163, AP2.0164, AP2.0165, AP2.0167, AP2.0170, AP2.0171, AP2.0172, AP2.0173, AP2.0174, AP2.0176, AP2.0177, AP2.0178, AP2.0179, AP2.0180, AP2.0181, AP2.0182, AP2.0183, AP2.0184, AP2.0185, AP2.0186, AP2.0187, AP2.0188, AP2.0189, AP2.0190, AP2.0191, AP2.0192, AP2.0196, AP2.0198, AP2.0199, AP2.0200, AP2.0201, AP2.0202, AP2.0203, AP2.0204, AP2.0205, AP2.0206, AP2.0207, AP2.0211, AP2.0212, AP2.0213, AP2.0215, AP2.0216, AP2.0217, AP2.0218, AP2.0219, AP2.0220, AP2.0221, AP2.0222, AP2.0223, AP2.0224, AP2.0225, AP2.0226, AP2.0227, AP2.0228, AP2.0229, AP2.0230, AP2.0231, AP2.0232, AP2.0233, AP2.0235, AP2.0236, AP2.0237, AP2.0240, AP2.0241, AP2.0242, AP2.0243, AP2.0245, AP2.0247, AP2.0248, AP2.0250, AP2.0253, AP2.0254, AP2.0255, AP2.0256, AP2.0257, AP2.0258, AP2.0259, Ap2.0260, AP2.0261, AP2.0262, AP2.0265, AP2.0266, AP2.0267, AP2.0268, AP2.0269, AP2.0270, AP2.0271, AP2.0272, AP2.0273, AP2.0276, AP2.0277, AP2.0278, AP2.0280, AP2.0281, AP2.0282, AP2.0283, AP2.0285, AP2.0286, AP2.0287, AP2.0288, AP2.0289, AP2.0290, AP2.0292, AP2.0293, AP2.0294, AP2.0295, AP2.0296, AP2.0298, AP2.0299, AP2.0300, AP2.0301, AP2.0302, AP2.0303, AP2.0304, AP2.0305, AP2.0306, AP2.0307, AP2.0308, AP2.0309, AP2.0310, AP2.0311, AP2.0313, AP2.0314, AP2.0315, AP2.0316, AP2.0318, AP2.0321, AP2.0322, AP2.0323, AP2.0324, AP2.0325, AP2.0327, AP2.0329, AP2.0330, AP2.0331, AP2.0333, AP2.0334, AP2.0336, AP2.0337, AP2.0338, AP2.0339, AP2.0340, AP2.0341, AP2.0342, AP2.0343, AP2.0345, AP2.0347, AP2.0348, AP2.0349, AP2.0350, AP2.0351, AP2.0352, AP2.0353, AP2.0354, AP2.0355, AP2.0356, AP2.0357, AP2.0358, AP2.0359, AP2.0360, AP2.0361, AP2.0362, AP2.0364, AP2.0366, AP2.0367, AP2.0368, AP2.0369, AP2.0370, AP2.0371, AP2.0372, AP2.0373, AP2.0374, AP2.0376, AP2.0377, AP2.0378, AP2.0379, APT.0009, APT.0014, APT.0058, APT.0065, APT.0093, APT.0091, APT.0136, APT.0247

Quantity recalled313

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-1889-2020
FDA event ID: 85429
Recalling firm: Inpeco, Lugano, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 7 Apr 2020
FDA classified: 5 May 2020
Reported: 13 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Medical Software

Timeline

7 Apr 2020	Recall initiated by company
5 May 2020	Classified by FDA	+28 days
13 May 2020	Published in enforcement report	+8 days

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

Reason for recall

The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

Product as listed by the FDA

Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf

Where it was distributed

Worldwide distribution including the following states: Ohio, New York, Virginia, Pennsylvania, Texas, Delaware, California, Florida, Kentucky, Tennessee, Maryland, Rhode Island, Alabama, Massachusetts, Connecticut, Minnesota, Alabama, Montana, Louisiana, New Jersey, Virginia, New Hampshire, Michigan, North Carolina, Washington, Iowa, New Mexico, Nebraska, and Missouri

Alabama California Connecticut Delaware Florida Iowa Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Montana North Carolina Nebraska New Hampshire New Jersey New Mexico New York

Questions about this recall

Why was it recalled?

The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

Which lots are affected?

Serial Numbers: AP2.0001, AP2.0002, AP2.0005, AP2.0008, AP2.0010, AP2.0011, AP2.0012, AP2.0013, AP2.0014, AP2.0016, AP2.0018, AP2.0019, AP2.0023, AP2.0024, AP2.0025, AP2.0026, AP2.0027, AP2.0032, AP2.0033, AP2.0034, AP2.0036, AP2.0039, AP2.0041, AP2.0042, AP2.0044, AP2.0045, AP2.0046, AP2.0047, AP2.0049, AP2.0050, AP2.0051, AP2.0052, AP2.0053, AP2.0054, AP2.0055, AP2.0056, AP2.0057, AP2.0058, AP2.0059, AP2.0060, AP2.0061, AP2.0062, AP2.0063, AP2.0064, AP2.0065, AP2.0067, AP2.0068, AP2.0070, AP2.0071, AP2.0072, AP2.0073, AP2.0074, AP2.0075, AP2.0076, AP2.0077, AP2.0078, AP2.0080, AP2.0081, AP2.0082, AP2.0083, AP2.0084, AP2.0085, AP2.0087, AP2.0088, AP2.0089, AP2.0090, AP2.0091, AP2.0092, AP2.0093, AP2.0094, AP2.0095, AP2.0097, AP2.0098, AP2.0099, AP2.0100, AP2.0101, AP2.0103, AP2.0105, AP2.0106, AP2.0107, AP2.0108, AP2.0109, AP2.0110, AP2.0111, AP2.0112, AP2.0113, AP2.0114, AP2.0115, AP2.0116, AP2.0117, AP2.0118, AP2.0119, AP2.0120, AP2.0121, AP2.0122, AP2.0123, AP2.0124, AP2.0125, AP2.0126, AP2.0127, AP2.0129, AP2.0130, AP2.0132, AP2.0133, AP2.0135, AP2.0136, AP2.0137, AP2.0138, AP2.0140, AP2.0141, AP2.0142, AP2.0143, AP2.0144, AP2.0145, AP2.0146, AP2.0147, AP2.0148, AP2.0149, AP2.0150, AP2.0151, AP2.0153, AP2.0154, AP2.0155, AP2.0156, AP2.0158, AP2.0159, AP2.0160, AP2.0161, AP2.0162, AP2.0163, AP2.0164, AP2.0165, AP2.0167, AP2.0170, AP2.0171, AP2.0172, AP2.0173, AP2.0174, AP2.0176, AP2.0177, AP2.0178, AP2.0179, AP2.0180, AP2.0181, AP2.0182, AP2.0183, AP2.0184, AP2.0185, AP2.0186, AP2.0187, AP2.0188, AP2.0189, AP2.0190, AP2.0191, AP2.0192, AP2.0196, AP2.0198, AP2.0199, AP2.0200, AP2.0201, AP2.0202, AP2.0203, AP2.0204, AP2.0205, AP2.0206, AP2.0207, AP2.0211, AP2.0212, AP2.0213, AP2.0215, AP2.0216, AP2.0217, AP2.0218, AP2.0219, AP2.0220, AP2.0221, AP2.0222, AP2.0223, AP2.0224, AP2.0225, AP2.0226, AP2.0227, AP2.0228, AP2.0229, AP2.0230, AP2.0231, AP2.0232, AP2.0233, AP2.0235, AP2.0236, AP2.0237, AP2.0240, AP2.0241, AP2.0242, AP2.0243, AP2.0245, AP2.0247, AP2.0248, AP2.0250, AP2.0253, AP2.0254, AP2.0255, AP2.0256, AP2.0257, AP2.0258, AP2.0259, Ap2.0260, AP2.0261, AP2.0262, AP2.0265, AP2.0266, AP2.0267, AP2.0268, AP2.0269, AP2.0270, AP2.0271, AP2.0272, AP2.0273, AP2.0276, AP2.0277, AP2.0278, AP2.0280, AP2.0281, AP2.0282, AP2.0283, AP2.0285, AP2.0286, AP2.0287, AP2.0288, AP2.0289, AP2.0290, AP2.0292, AP2.0293, AP2.0294, AP2.0295, AP2.0296, AP2.0298, AP2.0299, AP2.0300, AP2.0301, AP2.0302, AP2.0303, AP2.0304, AP2.0305, AP2.0306, AP2.0307, AP2.0308, AP2.0309, AP2.0310, AP2.0311, AP2.0313, AP2.0314, AP2.0315, AP2.0316, AP2.0318, AP2.0321, AP2.0322, AP2.0323, AP2.0324, AP2.0325, AP2.0327, AP2.0329, AP2.0330, AP2.0331, AP2.0333, AP2.0334, AP2.0336, AP2.0337, AP2.0338, AP2.0339, AP2.0340, AP2.0341, AP2.0342, AP2.0343, AP2.0345, AP2.0347, AP2.0348, AP2.0349, AP2.0350, AP2.0351, AP2.0352, AP2.0353, AP2.0354, AP2.0355, AP2.0356, AP2.0357, AP2.0358, AP2.0359, AP2.0360, AP2.0361, AP2.0362, AP2.0364, AP2.0366, AP2.0367, AP2.0368, AP2.0369, AP2.0370, AP2.0371, AP2.0372, AP2.0373, AP2.0374, AP2.0376, AP2.0377, AP2.0378, AP2.0379, APT.0009, APT.0014, APT.0058, APT.0065, APT.0093, APT.0091, APT.0136, APT.0247

Where was it sold?

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

Other products in this recall event

2 other products · FDA event 85429

This product is part of a recall event; the main page for the event is Abbott Accelerator a3600 Centrifuge Module tube loading recalled.

Reported	Class	Recall	Company	Reason	Where
13 May 2020	CLASS II	Abbott Accelerator a3600 Centrifuge Module tube loading recalled	Inpeco	Other	27 states
13 May 2020	CLASS II	FlexLab Centrifuge Module tube loading algorithm, Inpeco SA recalled	Inpeco	Other	27 states

More recalls from Inpeco

All 33

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025Device	CLASS II	FlexLab (FLX) recalled by Inpeco	Inpeco	Other	MI
3 Dec 2025Device	CLASS II	FlexLab (FLX) recalled by Inpeco	Inpeco	Other	MI
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	Other	Nationwide

Other Medical Software recalls

All 932

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS III	Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Device Malfunction	CA
14 Oct 2026Device	CLASS II	Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems	Philips Medical Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide