Drug recall
LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The…
FDA recall event 74940 · Class III · Alere San Diego, Inc.
Key facts
| Event ID | 74940 |
|---|---|
| Recall numbers | Z-2778-2016 |
| Recalling firm | Alere San Diego, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. |
| Initiation date | Aug 2, 2016 |
| Report date | Sep 21, 2016 |
| Termination date | Oct 28, 2016 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 1000125596 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: