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Ongoing FDAEvent 99409 (20 days ago)

McKesson, Alere, Fisher Scientific, and Henry Schein hCG Tests

HCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Alere San Diego, Inc. recalled hCG rapid tests because they may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. The recall began August 20, 2026, and was added to the FDA's Enforcement Report on September 25, 2026.

Summary by Recall Canary from the FDA notice.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is your cassette affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

  1. Product details

    Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527;
    McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000;
    Henry Schein One Step+ hCG Urine Strip Test, Model/ Part: FHC-101/9004072;
    Alere hCG Dipstick (25mIU/mL) in Urine, Model/ Part: FHC-101/92211;
    Cardinal Health hCG Dipstick Rapid Test CLIA Waived, Model/ Part: FHC-101/B-1077-21;
    Medline hCG Pregnancy Test Strip, Model/ Part: FHC-101/MPH11025HCG;
    Pro Advantage by NDC Urine Pregnancy Test Strip, Model/ Part: FHC-101/P080023;

    UDI-DI
    • 23900527
    • 00613647000588
    • 1155811305
    • 20612479202751
    • 40008059
    • 10304040024093
    • 1155800504
    • 10815845020093
    • 40008089
    • 20885380020244
    • 40008054
    • 10884389191873
    • 40006717
    • 40008087
    Lot
    All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900527/00613647000588/1155811305, 2018-01-15; 5000/20612479202751/40008059, V05; 9004072/10304040024093/1155800504, 2014-06-09; 92211/10815845020093/40008089, 05/25; B-1077-21/20885380020244/40008054, 04/2025; MPH11025HCG/10884389191873/40006717, 6/2025; P080023/M220P0800233/40008087, 2025-05-09

  2. Product details

    McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001;
    Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210;
    Fisher Scientific Sure-Vue Serum/Urine¿hCG-STAT, Model/ Part: FHC-A202/23900531, FHC-A202/23900530;
    McKesson CONSULT Diagnostics hCG Urine Cassette, Model/ Part: FHC-A202/5002;
    Alere hCG Combo Cassette (20/10 mIU/mL) for Urine or Serum, Model/ Part: FHC-A202/92215;
    Cardinal Health hCG Combo Rapid Test Serum or Urine, Model/ Part: FHC-A202/B-1077-23;
    Medline hCG Combo Pregnancy Test Cassette, Model/ Part: FHC-A202/MPH22025HCG;

    UDI-DI
    • 20612479202744
    • 1155958203
    • 10815845020130
    • 1156015803
    • 23900530
    • 00613647000571
    • 1155810105
    • 23900531
    • 00613647000533
    • 20612479202768
    • 1155958305
    • 10815845020123
    • 1156015903
    • 20885380020268
    • 1155904805
    • 10884389191880
    • 1156093402
    Lot
    All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 5001/ 20612479202744/1155958203, 12/15; 92210/10815845020130/1156015803, 07/16; 23900530/00613647000571/1155810105, 2018-01-15; 23900531/00613647000533/1155810105, 2018-01-15; 5002/20612479202768/1155958305, 12/15; 92215/10815845020123/1156015903, 07/16; B-1077-23/20885380020268/1155904805, 9/2014; MPH22025HCG/10884389191880/1156093402, 04-01-2015

  3. Product details

    Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528;
    Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025;
    Henry Schein One Step+ hCG Combo test in Serum or Urine, Model/ Part: FHC-202/9004075;
    Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum, Model/ Part: FHC-202/92225;
    Pro Advantage By NDC Urine/Serum Pregnancy Cassette Device, Model/ Part: FHC-202/P080021

    UDI-DI
    • 23900529
    • 00613647000540
    • 1155810906
    • 23900528
    • 00613647000564
    • 15099590776886
    • 10304040024123
    • 1155875804
    • 10815845020116
    • 1156015603
    • 40001856
    Lot
    All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900529/00613647000540/1155810906, 2018-01-15; 23900528/00613647000564/1155810906, 2018-01-15; 43025/15099590776886/May 2015; 9004075/10304040024123/1155875804, 2014-06-09; 92225/10815845020116/1156015603, 07/16; P080021/M220P0800213/40001856, 2023-03-30

  4. Product details

    Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526;
    Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073;
    Alere hCG Cassette (25mIU/mL) in Urine, Model/ Part: FHC-102/92217;
    Cardinal Health hCG Cassette Rapid test CLIA Waived, Model/ Part: FHC-102/B1077-22;
    Medline HCG Pregnancy Test Cassette, Model/ Part: FHC-102/MPH12025HCG;
    Pro Advantage By NDC Urine Pregnancy Cassette Device, Model/ Part: FHC-102/P080063;

    UDI-DI
    • 23900526
    • 00613647000526
    • 1155811105
    • 10304040024116
    • 1155875704
    • 10304040024109
    • 10815845020109
    • 1156015703
    • 20885380020251
    • 1155904704
    • 10888277191877
    • 1156093302
    • 40001853
    Lot
    All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900526/00613647000526/1155811105, 2018-01-15; 9004074/10304040024116/1155875704, 2014-06-09; 9004073/10304040024109/1155875704, 2014-06-09; 92217/10815845020109/1156015703, 07/16; B1077-22/20885380020251/1155904704, 9/2014; MPH12025HCG/10888277191877/1156093302, 2015-03-20; P080063/M220P0800633/40001853, 2023-03-30

Details

Company began the recall
Sold in

Worldwide - US Nationwide distribution including in the states of Illinois, Pennsylvania, Florida, Georgia, Virginia, New York, Tennessee, Arizona, Idaho, North Dakota, Wisconsin, Alabama, Louisiana, New Jersey,Montana, Nebraska, Ohio, PR, Indiana, Michigan, Wyoming, Massachusetts, California, Texas, Hawaii, Kansas, Kentucky, Arkansas, Colorado, North Carolina, Washington, Iowa, Minnesota, Oklahoma, Oregon, New Mexico, South Carolina, GU, Maryland, Nevada, Mississippi, West Virginia, South Dakota, Vermont, Delaware and the countries of United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden.

Event ID
99409
Recall numbers
Z-3271-2026 to Z-3274-2026
Company
Alere San Diego, Inc.San Diego, California
Hazard
Device defect

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. Summary updated

  5. In FDA's weekly enforcement report

More medical device recalls

See all

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration