Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA. Intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases.
FDA Recall Z-1479-2011 · Posted 2011-03-02
Advertisement
Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeLKJ
Date Initiated2010-03-01
Date Terminated2011-03-11
Product Quantity2,109 bulk packs
Reason for Recall
The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability.
Firm Action
An Urgent: Medical Device Recall Notification, dated March 1, 2010, was provided to the firm's consignee, identifying the affected product and stating the reason for the recall. The letter also asked the customer to examine their inventory and quarantine the affected kits. If the product had been further distributed, those customers must be identified, notified, and asked to discontinue use of the affected product. Customers were to discard all affected product and complete and return the enclosed Medical Device Recall Response Form. The letter also stated that replacement kits would be available in mid-March.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution -- New York, US.
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.
Advertisement