Reported Sep 23, 2015 · Terminated

The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue…

Leica Microsystems, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: Leica Microsystems, Inc. · 1700 Leider Ln · Buffalo Grove, IL · 60089-6622

Is this the product you have?

  • The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
Lot codes and dates
  • Product CodeLeica
  • ASP200S/ASP300S with Serial Numbers

    79 of 79 codes

    • 5682
    • 5886
    • 5264
    • 5267
    • 5356
    • 5259
    • 5956
    • 5946
    • 5794
    • 5385
    • 5929
    • 5301
    • 5401
    • 5310
    • 5530
    • 5909
    • 5804
    • 5272
    • 5724
    • 5796
    • 5807
    • 5446
    • 5435
    • 5670
    • 5947
    • 5348
    • 5434
    • 5388
    • 5366
    • 6000
    • 6131
    • 5407
    • 6040
    • 5799
    • 5815
    • 5737
    • 5706
    • 5381
    • 5416
    • 5673
    • 5875
    • 5962
    • 6041
    • 6042
    • 5266
    • 5948
    • 5693
    • 6021
    • 5610
    • 5798
    • 5926
    • 5387
    • 5349
    • 5273
    • 6115
    • 5612
    • 5965
    • 5955
    • 5260
    • 5725
Amount recalled
901

Where it was sold

Why it was recalled

The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 5, 2017 · Data as of Sep 19, 5:25 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.