Recall Z-3271-2026— Alere San Diego, Inc.

Name: FDA recall Z-3271-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-20

Class II · Ongoing

Class II FDA medical device recall by Alere San Diego, Inc., initiated 2026-08-20. It names one FDA 510(k) clearance: K062361. Product: 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/Urine¿hCG-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;. Reason: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result..

Recalling firm: Alere San Diego, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-20
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K062361 — INNOVACON HCG UKTRA TEST DEVICEInnovacon, Inc.·cleared 2006-10-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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/Urine¿hCG-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;

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.