Class 2 Device Recall hCG Pregnancy Test Device (Urine/Serum)

• Date Initiated by Firm: August 20, 2026
• Date Posted: September 25, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3272-2026
• Recall Event ID: 99409
• 510(K)Number: K993065
• Product Classification: Visual, pregnancy hCG, prescription use - Product Code JHI
• Product: 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
• Code Information: 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
• FEI Number: 1000125596
• Recalling Firm/ Manufacturer: Alere San Diego, Inc.; 9942 mesa rim rd; San Diego CA 92121-2997
• For Additional Information Contact: Monika Burrell; 858-805-2506 Ext. 3015
• Manufacturer Reason for Recall: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
• FDA Determined Cause: Device Design
• Action: On 8/20/2026, correction notices started being emailed to customers and distributors informing them to take the following actions: 1) In situations where an unexpected test result is obtained, consider all limitations, including peri-menopause that may result in low levels of hCG. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated, and an alternate confirmatory test that supports a timely clinical decision has been considered. 2) If you have forwarded affected products to other laboratories within your distribution network, notify them of this Field Corrective Action and provide them with a copy of this letter. 3) Retain this letter for your records. 4) Acknowledge receipt of this letter. Your organization s reply provides us with the necessary documentation to monitor the effectiveness of the field action notification. If you have questions regarding this information, U.S. Customers please contact the firm's Technical Services at 877-308-8289
• Quantity in Commerce: 5,331,585
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JHI