FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories Inc: 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.
- Recall number
- Z-1479-2011
- Recalling firm
- Bio-Rad Laboratories Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-03-01
- Posted
- 2011-03-02
- Terminated
- 2011-03-11
- Reason
- The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 2,109 bulk packs
- Distribution
- Nationwide Distribution -- New York, US.
- Lot, serial or model codes
- Lot Numbers: 24591524, exp 10/31/2010; 24591936, exp 12/31/2010; and 24500022, exp 12/31/2010.
- 510(k) numbers
- ["K954723"]
- PMA numbers
- not on file
- Product code
- LKJ
- Firm FEI
- 2915274
- Firm city
- Hercules
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28