Recall Z-1140-03 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Perkinelmer Life Sciences, Inc.
Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103
| Date | Aug 20, 2003 (initiated Jul 21, 2003) |
| Status | Terminated |
| Reason | Product's outer carton label was labeled with an extended expiration date |
| Root cause | Other |
| Action | PerkinElmer notified customers by telephone on 7/21/2003 of the expiration date error on the outer carton label . A recall letter issued on 7/25/03 and a verification form was requested to be completed and returned. |
| Quantity | 69 kits |
| Distribution | CA, PA, IN, MO Foreign: Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K843347 | RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON E.I. Dupont DE Nemours & Co., Inc., Oct 5, 1984 |