Alere hCG Pregnancy Test Cassettes Recalled for False Positive Results
Alere San Diego is recalling hCG rapid test cassettes because they may detect low hormone levels, leading to false positive pregnancy results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic) where injury or adverse health consequences have not yet been reported, fitting the High severity criteria for theoretical risk.
Plain-English summary
Alere San Diego, Inc. is recalling multiple models of hCG rapid test cassettes, including McKesson CONSULT, Alere, Fisher Scientific Sure-Vue, Cardinal Health, and Medline brands. The recall covers approximately 50.3 million units distributed worldwide, including nationwide distribution in the United States and various international locations.
The recall is being issued because these rapid tests may detect low levels of human chorionic gonadotropin (hCG) below the stated assay sensitivity. This defect may result in false positive results, potentially indicating pregnancy when it is not present.
Healthcare providers and consumers who have used or possess these test cassettes should stop using them. Users should consult with a healthcare professional for appropriate follow-up testing if a false positive result is suspected.
The recalled product
- 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…
- Manufacturer
- Alere San Diego, Inc.
- Category
- Medical Device — Pregnancy Test
- Hazard
- Affected units
- 50,265,835
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 12/15
- 92210/10815845020130/1156015803
- 07/16
- 23900530/00613647000571/1155810105
- 2018-01-15
- 23900531/00613647000533/1155810105
- 5002/20612479202768/1155958305
- 92215/10815845020123/1156015903
- B-1077-23/20885380020268/1155904805
- 9/2014
- MPH22025HCG/10884389191880/1156093402
- 04-01-2015
Distribution
Related recalls
Same manufacturer · Alere San Diego, Inc.
See all →- ModerateAlere hCG Urine Test Strips Recalled for False Positive Risk
FDA (Devices) · 2026-10-07
- ModerateAlere Recalls hCG Pregnancy Tests Due to False Positive Risk
FDA (Devices) · 2026-10-07
- HighAlere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
- HighAbbott Cholestech LDX Battery Kit Recall: Potential Swelling Risk
FDA (Devices) · 2024-05-08
- ModerateCholestech LDX cholesterol test cassettes require bilirubin interference label update
FDA (Devices) · 2022-08-17
Same hazard · false positive result
See all →- HighSequencing Agent SEQ0067 Component Recalled for Potential False-Positive Results
FDA (Devices) · 2026-04-29
- HighStratus CS Acute Care cTNI TestPak cardiac troponin test recall
FDA (Devices) · 2025-05-07
- HighBlood Culture Identification Panel May Produce False Positive Results
FDA (Devices) · 2024-08-07
- HighbiokitHSV-2 Rapid Test Recalled for Potential False Positive Results
FDA (Devices) · 2023-02-01
- ModerateSiemens Allergen Test Kit Recall: False Positive Mold Results
FDA (Devices) · 2022-12-21
Similar recalls
- HighAlere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
- ModerateAlere Recalls hCG Pregnancy Tests Due to False Positive Risk
FDA (Devices) · 2026-10-07
- ModerateAlere hCG Urine Test Strips Recalled for False Positive Risk
FDA (Devices) · 2026-10-07
- ModerateAlere hCG Combo Cassette Kits Recalled for Incorrect Packaging Inserts
FDA (Devices) · 2013-06-05
- LowAlere Recalls Cardinal Health hCG Cassette Rapid Test Due to Packaging Error
FDA (Devices) · 2013-05-29
- HighAlere Fertility Test Pregnancy Test Kits Recalled Due to Temperature Damage
FDA (Devices) · 2022-08-31