Alere Recalls Cardinal Health hCG Cassette Rapid Test Due to Packaging Error
Alere San Diego is recalling 2,167 Cardinal Health hCG Cassette Rapid Test kits because they were incorrectly packaged in boxes for a different test type.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the use of the product is not likely to cause adverse health consequences. The issue is a packaging/labeling error rather than a product defect or contamination.
Plain-English summary
Alere San Diego, Inc. is recalling 2,167 units of the Cardinal Health hCG Cassette Rapid Test (Part Number: B1077-22, Mfg PN: 4582105026). The recall is due to a packaging error where these specific kits were incorrectly placed into boxes designated for the Cardinal Health hCG Combo Rapid Test.
The affected kits are distributed nationwide across the United States. The primary issue is that the packaging incorrectly indicates that the product may be used for both urine and serum sample types, whereas the hCG Cassette Rapid Test is intended for professional use with urine samples only.
Healthcare professionals and consumers who possess this specific product should stop using it and contact Alere San Diego for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of…
- Manufacturer
- Alere San Diego, Inc.
- Category
- Medical Device — Pregnancy Test
- Hazard
- Affected units
- 2,167
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 (1)
- Lot: hCG2080330
Distribution
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