Reported Mar 20, 2013 · Terminated

ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement:…

Innominata dba Genbio

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: Innominata Dba Genbio · 15222 Avenue Of Science Ste A · San Diego, CA · 92128-3422

Is this the product you have?

  • ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960
  • Package Insert SupplementCalibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease
Lot codes and dates
    • Lot #120960 (121003. 121058
    • 121002)
    • Exp./Cad/Verw/bis: 2013-09
    • Catalog#802-3011
    • 25271
    • 25272
    • 25273
    • Label P/N 522-0040
    • 522-0037
    • 522-0011
Amount recalled
195

Where it was sold

Why it was recalled

Multiple incidents of low-reacting assay plates.

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 Aug 27, 2013 · Data as of Sep 19, 7:33 PM UTC

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