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Terminated

Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.

FDA Recall Z-0612-2011 · Posted 2010-12-13

Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeLKJ
Date Initiated2010-06-24
Date Terminated2011-08-08
Product Quantity37 units

Reason for Recall

Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass..

Firm Action

Bio-Rad issued Medical Device Recall Notification letters dated June 24, 2010 to consignees, identifying the affected products and requested that all affected product be disposed of in accordance with local procedures. Response forms are to be completed and returned to the firm. Bio-Rad can be contacted for replacement product and about this recall at 510 741-6114.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution: including the states of California, Ohio, Massachusetts, and Missouri. Product delivered to 11 consignees only in the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K954723ENZYME IMMUNOASSAY ANA SCREENING TEST KITHelix Diagnostics, Inc. · 1995-12-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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