Reported Aug 31, 2022 · Ongoing

a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests,…

Mckesson Medical-Surgical Inc. Corporate Office

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: Mckesson Medical-Surgical Inc. Corporate Office · 9954 Maryland Drive · Richmond, VA · 23233

Is this the product you have?

  • a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests
  • Model Number92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy
  • Test Urine Sample 50 Tests Model Number92211
Lot codes and dates
  • GTIN
    • a. 10815845020130
    • 00815845020133. b. 10815845020093
    • 00815845020096
Amount recalled
a. 5 kits b. 12 kits

This recall covers 55 products

The agency filed one notice per product. You are reading one of them; the other 54 are below.

42 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

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

Data as of Sep 19, 5:35 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.