Reported Feb 24, 2016 · Terminated

EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic…

Bio-Rad Laboratories, 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: Bio-Rad Laboratories, Inc. · 6565 185th Ave NE · Redmond, WA · 98052-5039

Is this the product you have?

  • EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual
  • in vitro diagnostic Product UsageEVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays
Lot codes and dates
  • The EVOLIS Microplate System instrument is not lot controlled, however for traceability purposes each instrument is assigned a unique serial number
  • SERIAL NUMBERS

    278 of 278 codes

    • 9163700126
    • 9163700175
    • 9163700187
    • 9163700196
    • 9163700208
    • 9163700210
    • 9163700231
    • 9163700266
    • 9163700278
    • 9163700320
    • 9163700328
    • 9163700336
    • 9163700337
    • 9163700349
    • 9163700354
    • 9163700368
    • 9163700402
    • 9163700431
    • 9163700449
    • 9163700478
    • 9163700480
    • 9163700481
    • 9163700495
    • 9163700498
    • 9163700499
    • 9163700501
    • 9163700510
    • 9163700527
    • 9163700530
    • 9163700531
    • 9163700544
    • 9163700556
    • 9163700558
    • 9163700559
    • 9163700560
    • 9163700567
    • 9163700585
    • 9163700587
    • 9163700594
    • 9163700595
    • 9163700623
    • 9163700624
    • 9163700625
    • 9163700629
    • 9163700656
    • 9163700695
    • 9163700696
    • 9163700722
    • 9163700743
    • 9163700744
    • 9163700745
    • 9163700764
    • 9163700765
    • 9163700772
    • 9163700775
    • 9163700776
    • 9163700810
    • 9163700821
    • 9163700822
    • 9163700823
Amount recalled
278 units

Where it was sold

  • Nationwide
  • PR

Why it was recalled

The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 13, 2017 · Data as of Sep 19, 5:18 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.