FlexLab X FXXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640172344002), received between Nov 11, 2025 and May 8, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Output Problem” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

31 other recalls cover devices cleared under the same FDA submission (K121012); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 30, 2025Open, Classified

   The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes

   Z-0596-2026 · Root cause: Device Design · FDA record ↗

2. Sep 3, 2025Open, Classified

   The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.

   Z-0107-2026 · Root cause: No Marketing Application · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Use of Device Problem

  THE CUSTOMER REPORTED AN ISSUE INVOLVING THE REPORTING OF MONONUCLEAR (MN) AND POLYMORPHONUCLEAR (PMN) BODY FLUID CELL COUNTS WITHIN THE FLEXLAB X WORKFLOW. THE PROBLEM WAS IDENTIFIED ON (B)(6) 2026, WHEN THE LABORATORY NOTICED THAT MN AND PMN RESULTS DISPLAYED IN THE LABORATORY INFORMATION SYSTEM (LIS) DID NOT CORRESPOND TO THE VALUES DISPLAYED BY THE ANALYZER INTERFACE. ACCORDING TO THE INFORMATION PROVIDED, THE RESULTS FOR MONONUCLEAR CELLS WERE DISPLAYED AS POLYMORPHONUCLEAR IN THE LIS, AND VICE VERSA. ACCORDING TO THE INFORMATION SHARED BY THE DISTRIBUTOR, THE MISREPORTING OCCURRED BETWEEN (B)(6) 2026. DURING THIS PERIOD, 15 SAMPLES FROM 8 PATIENTS WERE AFFECTED. FOR ONE OF THEM, THE INVERTED MN/PMN VALUES CONTRIBUTED TO THE CONTINUATION OF UNNECESSARY ANTIBIOTIC THERAPY FOR APPROXIMATELY TWO ADDITIONAL DAYS.

  Patient problems: Insufficient Information

  MAUDE report 25121569 ↗
• MalfunctionNov 11, 2025Output Problem; Output Problem

  THE CUSTOMER REPORTED AN OCCURRENCE OF AN ALREADY KNOWN ISSUE OF THE ALIQUOTER MODULE X (MALX). THE MALX MAY GENERATE SECONDARY SAMPLE TUBES WITHOUT LABELS OR WITH A LABEL REPORTING INFORMATION INCONSISTENT WITH THE ACTUAL SAMPLE DISPENSED INTO THE TUBE. THE EVENT OCCURS IF THE OPERATORS OPEN THE PRINTER HEAD OF THE MALX AND DO NOT EMPTY THE PRINTER TUBES BUFFER REMOVING ALL THE SECONDARY SAMPLE TUBES. IN THIS CASE THE OPERATOR WAS RECOVERING THE ERROR M34CC "TUBE HOPPER MOVE TO UP POSITION FAILURE" WHICH DID NOT ACTUALLY REQUIRE TO OPEN THE PRINTER HEAD. IN THIS LABORATORY THE SECONDARY TUBES ARE SORTED INTO AN INPUT OUTPUT MODULE (IOX) OUTPUT RACK. FOR THE SECONDARY SAMPLE TUBE WITH THE WRONG INFORMATION PRINTED ON THE LABEL, IF THE RACK IS UNLOCKED FROM THE LANE AND THE TUBE IS RE-LOADED ON THE AUTOMATION SYSTEM OR IS TESTED OFF TRACK, THE MISMATCH BETWEEN THE LABEL INFORMATION AND ACTUAL SAMPLE CANNOT BE DETECTED AND THE EVENT MAY LEAD TO INCORRECT RESULTS. THE OPERATOR MAY BECOME AWARE OF THE MISMATCH WHEN THE IMPACTED SECONDARY TUBE IS UNLOADED IN A POSITION OF THE IOX RACK THAT DOESN'T MATCH THE ONE DISPLAYED ON THE USER GRAPHIC INTERFACE. FOR THE SECONDARY SAMPLE TUBE WITHO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523280 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121012. One submission often covers many models, so check the product and lot details in each record.

• Z-0595-2026 · Oct 30, 2025 · Open, Classified
  FlexLab (FLX); Version: FLX-217-10;
• Z-0106-2026 · Sep 3, 2025 · Open, Classified
  FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
• Z-0560-2024 · Nov 3, 2023 · Open, Classified
  Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample
• Z-1560-2023 · Mar 10, 2023 · Open, Classified
  Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP
• Z-1563-2023 · Mar 10, 2023 · Open, Classified
  Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-27
• Z-1562-2023 · Mar 10, 2023 · Open, Classified
  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:
• Z-1559-2023 · Mar 10, 2023 · Open, Classified
  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-
• Z-1561-2023 · Mar 10, 2023 · Open, Classified
  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
• Z-0087-2022 · Sep 10, 2021 · Open, Classified
  FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
• Z-2974-2020 · Aug 7, 2020 · Terminated
  Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Syst
• Z-2975-2020 · Aug 7, 2020 · Terminated
  Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Syst
• Z-2973-2020 · Aug 7, 2020 · Terminated
  FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Produc
• Z-0432-2021 · Jul 14, 2020 · Terminated
  FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate
• Z-0433-2021 · Jul 14, 2020 · Terminated
  Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to auto
• Z-0434-2021 · Jul 14, 2020 · Terminated
  Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Ana

…and 16 more.