| Date Initiated by Firm | July 21, 2003 |
|---|
| Date Posted | August 20, 2003 |
|---|
| Recall Status1 |
Terminated 3 on November 19, 2003 |
| Recall Number | Z-1140-03 |
|---|
| Recall Event ID |
26856 |
| 510(K)Number | K843347 |
|---|
| Product Classification |
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DHN
|
| Product | Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use
Catalog Number: NEA 103 |
|---|
| Code Information |
Lot Number: 181578 |
Recalling Firm/
Manufacturer |
Perkinelmer Life Sciences, Inc.
549 Albany Street
Boston MA 02118
|
| For Additional Information Contact | Cindy Lloyd
617-482-9595 |
|---|
Manufacturer Reason
for Recall | Product's outer carton label was labeled with an extended expiration date |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 69 kits |
|---|
| Distribution | CA, PA, IN, MO
Foreign: Switzerland
|
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = DHN
|
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