Alere hCG Combo Cassette Kits Recalled for Incorrect Packaging Inserts
Alere San Diego, Inc. is recalling 3,975 hCG Combo Cassette kits because some were packaged with the wrong product insert.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a minor labeling/packaging error (incorrect product insert) with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Alere San Diego, Inc. has initiated a recall of 3,975 Alere hCG Combo Cassette (20/10 mIU/mL) kits, part number 92215. The affected lots are hCG1110133 and hCG1110135, with expiration dates of 9/30/13 and 10/31/13. The products were distributed nationwide in the United States.
The recall was initiated because an investigation indicated that a portion of these kits were incorrectly packaged with the Alere hCG Cassette (20 mIU/mL) Product Insert (part number 92210) instead of the correct insert for the Combo Cassette. The incorrect insert contains information for a different product.
The Alere hCG Combo Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, used as an aid in the early detection of pregnancy. The product is intended for healthcare professionals only. Users should stop using the affected kits and contact the manufacturer for instructions.
The recalled product
- Product
- Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of…
- Manufacturer
- Alere San Diego, Inc.
- Category
- Medical Device — Pregnancy Test
- Hazard
- Affected units
- 3,975
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 (2)
- Lot/Unit Codes: hCG1110133 & hCG1110135 Part Number: 92215 Expiration date
- or Expected shelf life: 9/30/13 & 10/31/13
Distribution
Distributed nationwide across the United States.
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
- HighAlere hCG Pregnancy Test Cassettes Recalled for False Positive Results
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
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- LowAlere Recalls Cardinal Health hCG Cassette Rapid Test Due to Packaging Error
FDA (Devices) · 2013-05-29
- HighAlere hCG Pregnancy Test Cassettes Recalled for False Positive Results
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
- HighAlere Fertility Test Pregnancy Test Kits Recalled Due to Temperature Damage
FDA (Devices) · 2022-08-31
- ModerateAlere hCG Urine Test Strips Recalled for False Positive Risk
FDA (Devices) · 2026-10-07