Reported Mar 3, 2021 · Terminated

S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the…

Medline Industries 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: Medline Industries Inc · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

    • S-O303000 CONTROL
    • STAT-SITE B-HB
    • 2X3ML
    • 1LOW
    • 1HIGH -
  • Product Usageintended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only
Lot codes and dates
  • Model NumberS-O303000
  • Batch Numbers
    • 154950
    • 154590
    • 158668
    • 159370
    • 192532
    • 192891
    • 19365
    • 200831
  • Lot Number and/or Serial Number
    • 154950
    • 154590
    • 158668
    • 159370
    • 192532
    • 192891
    • 19365
    • 200831
Amount recalled
46 units

Where it was sold

Why it was recalled

Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Medline Industries Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 9, 2023 · Data as of Sep 19, 6:20 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.