Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103
FDA Recall Z-1140-03 · Posted 2003-08-20
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Recalling FirmPerkinelmer Life Sciences, Inc.
Recall StatusTerminated
Product CodeDHN
Date Initiated2003-07-21
Date Terminated2003-11-19
Product Quantity69 kits
Reason for Recall
Product's outer carton label was labeled with an extended expiration date
Firm 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.
Root Cause
Other
Distribution Pattern
CA, PA, IN, MO Foreign: Switzerland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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