Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 31, 2016
SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been vali
The batteries have the potential to overheating, melt or char.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Tecan US, Inc. recalled SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the m… - a moderate-severity action.
SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the 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-2661-2016 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..
- Moderate
- severity level
- 19 units
- affected scope
- Class II
- classification
- August 31, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2661-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2661-2016) 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 19 units.
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.
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 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
19 units
Related Recalls
6
3 from same agency
Product description
SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics
Reason for recall
The batteries have the potential to overheating, melt or char.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2661-2016 |
| Date reported | August 31, 2016 |
| Date initiated | July 25, 2016 |
| Recalling firm | Tecan US, Inc. |
| Firm location | Morrisville, NC |
| Affected scope | 19 units |
| 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.
- Check the recall number (Z-2661-2016) 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? ▼
SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics. Recalled by Tecan US, Inc.. Units affected: 19 units.
Why was this product recalled? ▼
The batteries have the potential to overheating, melt or char.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2016. Severity: Moderate. Recall number: Z-2661-2016.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2661-2016) 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 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.