Reported Aug 14, 2019 · Terminated

Assayed Bovine Multi-Sera Level 1, Model No. AL1027

Randox Laboratories, Limited

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: Randox Laboratories, Limited · Ardmore; 55 The Diamond Road · Crumlin, N/A · N/A

Is this the product you have?

    • Assayed Bovine Multi-Sera Level 1
    • Model No. AL1027
Lot codes and dates
  • 205SL
Amount recalled
4 kits (US)

This recall covers 2 products

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

Where it was sold

Why it was recalled

The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.

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 Jun 16, 2020 · Data as of Sep 19, 6:52 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.