FDA Device recall Z-2778-2016
LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert
- FDA Device
- Class III
- terminated
- Published 2016-09-21
On 2016-09-21 the FDA classified a Class III recall of LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert by Alere San Diego, citing incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2778-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-08-02 |
| Published | 2016-09-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Alere San Diego |
| Distribution | US |
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
Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
Identifiers
| code_info | Model Number: 10-228 and 14-535 Lot Number: 332994 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2778-2016%22
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