Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's IC
Summary
The FDA issued a Class II for Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-2 by Alere San Diego, Inc.. Reason: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result..
Details
Source
Device Recall
External ID
Z-3272-2026
Action Date
2026-10-07
Status
Ongoing
Category
device
Product Description
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
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
Quantity Affected: 5,331,585
Reason for Recall
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Distribution
Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-20
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 518 device-related FDA actions this month.
Alere San Diego, Inc. has 7 FDA actions in our database, including 6 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alere San Diego, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alere San Diego, Inc. have FDA actions?
Alere San Diego, Inc. has 7 FDA actions in our database, including 6 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3272-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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