CLASS II Device recall · Reported 23 Sep 2020 · FDA Enforcement Report
FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module recalled
Inpeco is recalling FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10, distributed nationwide in the US. The recall was initiated on 7 Aug 2020 and the FDA has classified it as Class II.
Check your package
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-2973-2020
- FDA event ID
- 86263
- Recalling firm
- Inpeco, Lugano, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Aug 2020
- FDA classified
- 16 Sep 2020
- Reported
- 23 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 7 Aug 2020 | Recall initiated by company | |
| 16 Sep 2020 | Classified by FDA | +40 days |
| 23 Sep 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, VA and the countries of AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, NETHERLANDS. NORWAY SAUDI ARABIA SOUTH KOREA SWEDEN UNITED ARAB EMIRATES
Nationwide AlaskaFloridaIowaLouisianaMassachusettsMississippiMontanaNorth CarolinaOhioTexasVirginia
Questions about this recall
Why was it recalled?
Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
Which lots are affected?
Serial Numbers: US: FLX.0133 FLX.0181 OUS: FLX.0048 FLX.0049 FLX.0121 FLX.0155 FLX.0160 FLX.0200
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, VA and the countries of AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, NETHERLANDS. NORWAY SAUDI ARABIA SOUTH KOREA SWEDEN UNITED ARAB EMIRATES
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 86263This product is part of a recall event; the main page for the event is Accelerator a3600 system with Sysmex XN-9000/XN recalled by Inpeco.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Accelerator a3600 system with Sysmex XN-9000/XN recalled by Inpeco | Inpeco | Potency & Assay | Nationwide | |
| CLASS II | Aptio Automation systems with Sysmex XN-9000/XN recalled by Inpeco | Inpeco | Potency & Assay | Nationwide |
More recalls from Inpeco
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | FlexLab (FLX) recalled by Inpeco | Inpeco | Other | MI |
| Device | CLASS II | FlexLab (FLX) recalled by Inpeco | Inpeco | Other | MI |
| Device | CLASS II | FlexLab (FLX) System recalled by Inpeco | Inpeco | Other | CA, NY |
| Device | CLASS II | FlexLab X (FXX) System recalled by Inpeco | Inpeco | Other | CA, NY |
| Device | CLASS II | Roche Cobas 8000 and Cobas PRO Interface Module recalled by Inpeco | Inpeco | Other | Nationwide |
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| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |