Recall Z-0208-04 ยท LGQ Fluorescence Polarization Immunoassay, Phenobarbital
Abbott Laboratories Diagnostic Div
AEROSET Phenobarbital, LN 1E08-01
| Date | Jul 20, 2004 (initiated Nov 3, 2003) |
| Status | Terminated |
| Reason | Assay is imprecise. |
| Root cause | Other |
| Action | Firm telephoned customers on 11/3/2003 and followed up with a letter offering credit or replacement. |
| Quantity | 112 |
| Distribution | Nationwide, Mexico, England and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.