Cardinal Health hCG Cassette Rapid Test — Class III medical device recall Z-1344-2013
Terminated recall by Alere San Diego, Inc., reported 2013-05-29, distributed nationwide. Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorr
| Recall number | Z-1344-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere San Diego, Inc., San Diego, CA, United States |
| Recall initiated | 2013-01-21 |
| Classified | 2013-05-21 |
| Reported by FDA | 2013-05-29 |
| Terminated | 2013-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 2,167 kits |
| Lot numbers | HCG2080330 |
| Model numbers | B1077-22 |
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 pregnancy. This test is for professional use.
Reason for recall
Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used for both urine and serum sample types.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1344-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.