The Recall Desk

Hazard

Sample Misidentification recalls

19 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
19
Critical
0
Severe
0
Most recent
2023-09-20

Of the 19 sample misidentification recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sample misidentification recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–19 of 19

  • HighFDA (Devices)·Z-2578-2023·2023-09-20

    Medical Device Recall: ACL TOP Coagulation Analyzers for Sample Misidentification

    Instrumentation Laboratory is recalling ACL TOP coagulation analyzers due to potential sample misidentification that could result in incorrect test results and alter patient management decisions.

    Product
    ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2023·2023-05-10

    Laboratory Automation Module Firmware May Cause Sample Misidentification

    Vesmatic Cube 80 laboratory automation system firmware can incorrectly identify patient samples, potentially leading to wrong test results and inappropriate treatment. Affected systems include FlexLab, Accelerator a3600, and Aptio Automation units.

    Product
    Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1559-2023·2023-05-10

    Laboratory automation module firmware may cause sample misidentification

    A firmware bug in Inpeco laboratory automation modules may cause sample misidentification, leading to incorrect electrolyte test results and potential treatment errors.

    Product
    Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2023·2023-05-10

    Laboratory Automation System Firmware May Misidentify Patient Samples

    Inpeco laboratory automation systems' firmware can misassociate patient samples, potentially leading to incorrect electrolyte test results. The defect is rare but could cause serious medical consequences if results are misidentified or delayed.

    Product
    PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0268-2023·2022-11-30

    Diagnostic System Software Defects Affecting Sample Processing and Test Accuracy

    Abbott is recalling 883 Alinity m diagnostic systems due to software defects affecting sample identification, system operation, and test calibration. The issues affect all serial numbers running software version 1.6.5.

    Product
    Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0087-2022·2021-10-20

    Automation System Interface Module Firmware May Misassociate Test Results to Samples

    Inpeco's automation interface module firmware may incorrectly associate laboratory test results with patient sample IDs, potentially causing incorrect patient results.

    Product
    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2141-2020·2020-06-03

    Inpeco Accelerator a3600 Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling three Accelerator a3600 Automation Systems due to a firmware communication error that can cause incorrect sample-tube associations.

    Product
    Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and Post-Analyt
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2142-2020·2020-06-03

    Inpeco Aptio Automation System Recalled for Sample Association Error

    Inpeco S.A. is recalling 70 Aptio Automation Systems with specific interface modules due to a firmware communication error that can cause erroneous sample-tube associations.

    Product
    Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0091-2018·2017-11-22

    Beckman Coulter AQUIOS CL Flow Cytometer Recalled for Sample Misidentification Risk

    Beckman Coulter is recalling 268 AQUIOS CL Flow Cytometers because the system may duplicate sample requests, leading to sample misidentification when connected to a Laboratory Information System.

    Product
    AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagen
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2064-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 500 CTS Coagulation Instruments

    Instrumentation Laboratory is recalling ACL TOP 500 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 500 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP CTS Coagulation Instruments

    Instrumentation Laboratory is recalling 572 ACL TOP CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2061-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 Coagulation Instruments

    Instrumentation Laboratory is recalling 633 ACL TOP 700 automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2060-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP Coagulation Instruments

    Instrumentation Laboratory Co. is recalling 1,074 ACL TOP (Base) automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP (Base), automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 LAS Coagulation Instruments

    Instrumentation Laboratory is recalling 99 ACL TOP 700 LAS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700 LAS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 CTS Coagulation Instruments

    Instrumentation Laboratory is recalling 266 ACL TOP 700 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2066-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 300 CTS Coagulation Instruments

    Instrumentation Laboratory Co. is recalling ACL TOP 300 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 300 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2014·2013-11-06

    Siemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Sample Misidentification Risk

    Siemens Healthcare Diagnostics Inc. is recalling RAPIDPoint 400 series blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0105-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1200 Series blood gas analyzers because users may enter the wrong patient ID, leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0056-2013·2012-10-24

    Beckman Coulter AutoMate 1250 and 2550 Sample Processing System Recall

    Beckman Coulter is recalling AutoMate 1250 and 2550 systems due to a risk of sample misidentification caused by duplicate barcode labels.

    Product
    AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling a
    Category
    Medical Device
    Distribution
    Distributed nationwide