Reported Jul 6, 2016 · Terminated

Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay…

Beckman Coulter 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: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Is this the product you have?

  • Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
Lot codes and dates
    • 524087
    • 526807
    • 528874
    • 529913
    • 530102
    • 531647
    • 532473
    • 534080
    • 534081
    • 534336
    • 535481
    • 570090
    • 570116
    • 570222
    • 570236
    • 570239
    • 570245
    • 570246
    • 622173
    • 622174
    • 671016
    • 671025
    • 671033
Amount recalled
205,744 kits total (13,358 kits in US)

Where it was sold

Why it was recalled

Demonstrate an upward shift in patient results.

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 Apr 18, 2017 · Data as of Sep 19, 6:00 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.