Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 18, 2020
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 Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. Th…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Inpeco S.a. recalled FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The Fle… - a moderate-severity action.
FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The Fle… was recalled by Inpeco S.a. in November 18, 2020. Reason: When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspira…. Check the official notice for the remedy. Verify recall #Z-0432-2021 with the FDA Devices before acting.
The recall
Inpeco S.a. issued this moderate-severity FDA Devices recall-When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspira….
- Moderate
- severity level
- 93 units
- affected scope
- Class II
- classification
- November 18, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0432-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0432-2021) was formally reported on November 18, 2020, with the manufacturer initiating the action on July 14, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Inpeco S.a. is listed as the recalling firm, operating out of Lugano. Federal records list the affected scope as 93.
The documented reason for this recall is: When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged wit… Distribution data in the federal record shows the product reached: Global Distribution including: USA and countries of: Algeria, Australia, Azerbaijan, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Finland, France, Germany, Indonesia, Israel, Italy, Libano, Mexico, N…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
93
Related Recalls
6
0 from same agency
Product description
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 Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
Reason for recall
When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0432-2021 |
| Date reported | November 18, 2020 |
| Date initiated | July 14, 2020 |
| Recalling firm | Inpeco S.a. |
| Firm location | Lugano |
| Affected scope | 93 |
| Distribution | Global Distribution including: USA and countries of: Algeria, Australia, Azerbaijan, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Finland, France, Germany, Indonesia, Israel, Italy, Libano, Mexico, Netherlands, Philippi… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0432-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.. Recalled by Inpeco S.a.. Units affected: 93.
Why was this product recalled? ▼
When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2020. Severity: Moderate. Recall number: Z-0432-2021.
Where was the recalled product distributed? ▼
Distribution: Global Distribution including: USA and countries of: Algeria, Australia, Azerbaijan, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Finland, France, Germany, Indonesia, Israel, Italy, Libano, Mexico, Netherlands, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and United Arab Emirates..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0432-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported November 18, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.