Reported Jul 8, 2015 · Terminated

Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator…

Tecan US, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Tecan US, Inc. · 9401 Globe Center Drive · Morrisville, NC · 27560

Is this the product you have?

  • Infinite M1000 PRO in vitro diagnostic
  • Product UsageThe Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as a external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards
Lot codes and dates
  • Material Number 30063849. Serial numbers

    140 of 140 codes

    • 1304002505
    • 1211001152
    • 1404000702
    • 1411000822
    • 1401004105
    • 1205001934
    • 1308000225
    • 1309006882
    • 1208001184
    • 1204007588
    • 1310005809
    • 1402004302
    • 1211001148
    • 1305006435
    • 1201003163
    • 1404003953
    • 1406001800
    • 1403005820
    • 1402003587
    • 1311007574
    • 1312002863
    • 1406000407
    • 1406004487
    • 1408007771
    • 1310007970
    • 1201003165
    • 1110002126
    • 1203007860
    • 1309000153
    • 1408007772
    • 1502004994
    • 1410008825
    • 1407000743
    • 1406004488
    • 1201007987
    • 1206005852
    • 1406008272
    • 1410008826
    • 1412004769
    • 1404006185
    • 1212002553
    • 1403008861
    • 1309000008
    • 1211004372
    • 1403000810
    • 1208009323
    • 1211001150
    • 1201003164
    • 1204006296
    • 1407000079
    • 1203002067
    • 1206003111
    • 1304004516
    • 1309000007
    • 1302004940
    • 1309000154
    • 1403000809
    • 1212005340
    • 1309000155
    • 1410000939
Amount recalled
868 in total

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

A firmware bug causes incorrect values to be displayed for specific measured luminescence values.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Tecan US, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 18, 2017 · Data as of Sep 19, 4:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.