LDX Optical Check Cassettes — Class III medical device recall Z-2778-2016
Terminated recall by Alere San Diego, Inc., reported 2016-09-21, distributed nationwide. Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
| Recall number | Z-2778-2016 |
|---|---|
| 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 | 2016-08-02 |
| Classified | 2016-09-09 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2016-10-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, JP |
| Quantity | 12,951 |
| Reason classes | labeling |
| Lot numbers | 332994 |
| Model numbers | 10-228, 14-535 |
Product
LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.
Reason for recall
Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
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-2778-2016. 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.