DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.
FDA Recall Z-1478-2011 · Posted 2011-03-02
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Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeLKJ
Date Initiated2010-03-01
Date Terminated2011-03-11
Product Quantity999 kits
Reason for Recall
Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.
Firm Action
Recall was initiated on 3/1/2010. DiaSorin S.R.I. (the sole consignee) was alerted via email using the firm's Medical Device Recall Notification. Consignee informed of the recall and instructed to dispose of the affected product according to local laws.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Foreign Only: One distributor, DiaSorin S.R.I. in Italy. No wholesalers. No retailers. No domestic distribution, No Federal Government sales/distribution centers.
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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