Severity
Moderate
FDA Devices recall · Reported August 31, 2016
The batteries have the potential to overheating, melt or char.
Tecan US, Inc. recalled Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based m… - a moderate-severity action.
Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based m… was recalled by Tecan US, Inc. in August 31, 2016. Reason: The batteries have the potential to overheating, melt or char.. Check the official notice for the remedy. Verify recall #Z-2664-2016 with the FDA Devices before acting.
The recall
Tecan US, Inc. issued this moderate-severity FDA Devices recall-The batteries have the potential to overheating, melt or char..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2664-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2664-2016) was formally reported on August 31, 2016, with the manufacturer initiating the action on July 25, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Tecan US, Inc. is listed as the recalling firm, operating out of Morrisville, NC. Federal records list the affected scope as 1 unit.
The documented reason for this recall is: The batteries have the potential to overheating, melt or char. Distribution data in the federal record shows the product reached: Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.. 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.
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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
1 unit
Related Recalls
6
3 from same agency
Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards
The batteries have the potential to overheating, melt or char.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2664-2016 |
| Date reported | August 31, 2016 |
| Date initiated | July 25, 2016 |
| Recalling firm | Tecan US, Inc. |
| Firm location | Morrisville, NC |
| Affected scope | 1 unit |
| Distribution | Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada. |
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.
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.
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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 August 31, 2016. 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.