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Terminated

Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog Number: 576AN manufactured by Bio-Rad, Hercules, CA.

FDA Recall Z-0540-2011 · Posted 2010-12-06

Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeLKJ
Date Initiated2010-03-01
Date Terminated2011-01-05

Reason for Recall

The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.

Firm Action

Bio-Rad issued an Urgent Medical Device Recall Notification letter dated March 1, 2010 to customers describing the issue and actions to be taken. Responses will be tracked via response forms. The letter instructed customers that affected products should be identified, quarantined, and discarded, or reworked with shorter expiration dates until newer lots are available. Bio-Rad can be contacted at 510-724-7000 concerning this recall.

Root Cause

Other

Distribution Pattern

Worldwide Distribution: Throughout the US, and to the countries of: Australia, Canada, France, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and the UK.

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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