Reported May 29, 2013 · Terminated

Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a…

Alere San Diego, 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: Alere San Diego, Inc. · 9975 Summers Ridge Rd · San Diego, CA · 92121-2997

Is this the product you have?

  • Cardinal Health hCG Cassette Rapid Test
  • Part NumberB1077-22 (Mfg
  • PN4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use
Lot codes and dates
  • LothCG2080330
Amount recalled
2,167 kits

Where it was sold

Why it was recalled

Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used for both urine and serum sample types.

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 Aug 28, 2013 · Data as of Sep 19, 6:15 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.