Drug recall
ISE-Electrolyte Systems VetLyte ISE Fluid Pack, for use only in VetLyte electrolyte analyzers, product…
FDA recall event 30722 · Class II · Roche Diagnostics Corp.
Key facts
| Event ID | 30722 |
|---|---|
| Recall numbers | V-081-5 |
| Recalling firm | Roche Diagnostics Corp. |
| Product type | Veterinary |
| Products | ISE-Electrolyte Systems VetLyte ISE Fluid Pack, for use only in VetLyte electrolyte analyzers, product 98-05318-00, manufactured for IDEXX Laboratories, Inc. Westbrook, Maine. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Initiation date | Dec 21, 2004 |
| City | Indianapolis |
| Country | United States |
| FEI number | 1823260 |
At a glance
- 1–9 Products in this recall
- None 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