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/UrinehCG-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;

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

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