Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported January 21, 2015
Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
Incorrect lumi firmware version installed (E.027 instead of V2.00)
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Tecan US, Inc. recalled Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injec… - a low-severity action.
Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injec… was recalled by Tecan US, Inc. in January 21, 2015. Reason: Incorrect lumi firmware version installed (E.027 instead of V2.00). Check the official notice for the remedy. Verify recall #Z-0992-2015 with the FDA Devices before acting.
The recall
Tecan US, Inc. issued this low-severity FDA Devices recall-Incorrect lumi firmware version installed (E.027 instead of V2.00).
- Low
- severity level
- Class III
- classification
- January 21, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0992-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0992-2015) was formally reported on January 21, 2015, with the manufacturer initiating the action on November 10, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Tecan US, Inc. is listed as the recalling firm, operating out of Morrisville, NC. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: Incorrect lumi firmware version installed (E.027 instead of V2.00) Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.. 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, 3 from FDA Devices - 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Unknown
Related Recalls
6
3 from same agency
Product description
Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
Reason for recall
Incorrect lumi firmware version installed (E.027 instead of V2.00)
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0992-2015 |
| Date reported | January 21, 2015 |
| Date initiated | November 10, 2014 |
| Recalling firm | Tecan US, Inc. |
| Firm location | Morrisville, NC |
| Affected scope | Not disclosed |
| Distribution | Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK. |
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-0992-2015) 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? ▼
Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.. Recalled by Tecan US, Inc..
Why was this product recalled? ▼
Incorrect lumi firmware version installed (E.027 instead of V2.00)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2015. Severity: Low. Recall number: Z-0992-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0992-2015) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 21, 2015. 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.