Class II U.S. Food and Drug Administration

Alere San Diego, Inc. Fisher Scientific Sure-Vue Serum/Urine hCG recall: hCG rapid tests may detect low levels of hCG below the stated assay

Recall published 18 days ago

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

The hazard: Device malfunction

The notice describes a specific failure mode. That detail is what a clinician needs, because the right action differs sharply between a monitor, an implant and a test kit.

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

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-3272-2026
Published
October 7, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Alere San Diego, Inc.
Product type
Medical devices
Units affected
5,331,585
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
00613647000540, 00613647000564, 15099590776886, 10304040024123, 10815845020116

Products covered by this recall

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

Check your product

The notice names 14 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00613647000540
  • 00613647000564
  • 15099590776886
  • 10304040024123
  • 10815845020116

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • UDI-DI

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • UDI-DI

Model or item number

On the rating label, the box or the instruction sheet.

  • FHC-202
  • 23900529
  • 23900528
  • 43025
  • 9004075
  • 92225
  • UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

Alere San Diego, Inc. — The notice describes a specific failure mode. That detail is what a clinician needs, because the right action differs sharply between a monitor, an implant and a test kit.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.
  3. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
  4. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Alere San Diego, Inc. — 9942 mesa rim rd, San Diego, CA, 92121-2997

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Alere San Diego, Inc. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00613647000540, 00613647000564, 15099590776886; lot code UDI-DI; best-by date UDI-DI; model number FHC-202, 23900529, 23900528. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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