FDA Device recall Z-0596-2026
FlexLab (FLX)
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of FlexLab (FLX) by Inpeco, citing 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 occur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0596-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-30 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Inpeco |
| Distribution | MI |
Product
FlexLab (FLX); Version: FLX-217-40;
Reason
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
Identifiers
| code_info | UDI-DI: 07640172344002; Serial number: FXX.0004, FXX.0006, FXX.0009, FXX.0022, FXX.0023, FXX.0024, FXX.0027, FXX.0028,…UDI-DI: 07640172344002; Serial number: FXX.0004, FXX.0006, FXX.0009, FXX.0022, FXX.0023, FXX.0024, FXX.0027, FXX.0028, FXX.0034, FXX.0036, FXX.0041, FXX.0042, FXX.0043, FXX.0046; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Inpeco
- FlexLab (FLX)
FDA Device · Class II · 2025-12-03 · Inpeco - FlexLab (FLX) System
FDA Device · Class II · 2025-10-15 · Inpeco - FlexLab X (FXX) System
FDA Device · Class II · 2025-10-15 · Inpeco - Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytic…
FDA Device · Class II · 2023-12-27 · Inpeco - Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Apti…
FDA Device · Class II · 2023-05-10 · Inpeco
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0596-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.