Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part…
Alere San Diego, Inc. · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Open FDA's page for this record- Cfres ID
- 222980
- Product res number
- Z-3272-2026
- Event date initiated
- 2026-08-20
- Event date posted
- 2026-09-25
- Recall status
- Open, Classified
- Res event number
- 99409
- Product code
- JHI
- Firm FEI number
- 1000125596
- Recalling firm
- Alere San Diego, Inc.
- Address 1
- 9942 mesa rim rd
- City
- San Diego
- State
- CA
- Postal code
- 92121-2997
- Additional info contact
- Monika Burrell 858-805-2506 Ext. 3015
- Reason for recall
- hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- Root cause description
- Device Design
- Product quantity
- 5,331,585
- 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
- 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
- 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
- Distribution pattern
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.
- K numbers
- K993065
- Harmonized identifiers (openFDA)
- Device name
- Visual, Pregnancy Hcg, Prescription Use
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.1155
- Device class
- 2
- K number
- K262299, K050955, K925435, K926342, K894790, K894750, K023823, K862007, K780679, K862262, K001215, K921211, K811398, K963132, K953486, K884880, K823313, K801244, K965227, K854958, K833194, K884616, K984076, K921212, K831221, K936031, K012284, K831223, K791206, K011550, K013194, K821234, K870259, K924673, K914240, K852327, K812156, K962906, K902681, K974159 +336 more
- Registration number
- 3004635103, 2050012, 8020888, 3011522054, 3005174594, 1645225, 1832216, 2027969, 2432235, 3043127647, 2025099, 3008951115, 3005984081, 2060833, 3010852191, 2032087, 3005345870, 3023322455, 3002637618, 9610633, 2025760, 2250030, 3013443462, 2246703, 3005630901, 8020790, 2087033, 3007838093, 1222302, 3003030793, 3027500452, 3033967997, 3005445066, 3030413233, 3015729142, 3017887566, 3005529799, 1649661, 3005360469, 3018126397 +72 more
- FEI number
- 3004635103, 2050012, 3011522054, 3005174594, 3001452245, 1832216, 2432235, 3043127647, 3008951115, 3005984081, 3010852191, 3005345870, 3023322455, 3003075526, 3002637618, 2025760, 2250030, 3013443462, 2246703, 3002564473, 3007019572, 3005630901, 1000121039, 3007838093, 3003030793, 3027500452, 3033967997, 1000126037, 3005670738, 3005445066, 3030413233, 3015729142, 3017887566, 3005529799, 3007981058, 3006078362, 3018126397, 2967, 1827821, 3014848805 +72 more