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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85429

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 07, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

3 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 3

Inpeco FlexLab 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

Z-1887-2020
Recall number
Z-1887-2020
Initiated
April 07, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Inpeco S.A.
Quantity
65 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Numbers: FLX.002, FLX.006, FLX.008, FLX.011, FLX.0121, FLX.0127, FLX.0128, FLX.0129, FLX.0132, FLX.0133, FLX.0139, FLX.014, FLX.0147, FLX.0149, FLX.0150, FLX.0153, FLX.0154, FLX.0160, FLX.0162, FLX.0167, FLX.0168, FLX.0172, FLX.0173, FLX.0174, FLX.0179, FLX.0180, FLX.0182, FLX.0191, FLX.0192, FLX.0193, FLX.0194, FLX.0197, FLX.0198, FLX.0201, FLX.0202, FLX.0203, FLX.0206, FLX.022, FLX.032, FLX.035, FLX.036, FLX.037, FLX.039, FLX.043, FLX.046, FLX.050, FLX.056, FLX.057, FLX.060, FLX.061, FLX.062, FLX.073, FLX.082, FLX.083, FLX.085, FLX.086, FLX.087, FLX.093, FLX.096, FLX.097, FLX.098, FLX.100, SHD.001, SHD.002, SHD.003

Distribution pattern

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

device · product 2 of 3

Abbott Accelerator a3600 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

Z-1888-2020
Recall number
Z-1888-2020
Initiated
April 07, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Inpeco S.A.
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Numbers: ACP.357, ACP.388, ACP.396, ACP.397, ACP.399, ACP.400, ACP.402, ACP.404, ACP.405, ACP.407, ACP.408, ACP.409, ACP.410, ACP.412, ACP.413, ACP.416, ACP.417, ACP.418, ACP.419, ACP.420, ACP.421, ACP.422, ACP.423

Distribution pattern

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

device · product 3 of 3

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

Z-1889-2020
Recall number
Z-1889-2020
Initiated
April 07, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Inpeco S.A.
Quantity
313

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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