FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories: Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.
- Recall number
- Z-0065-2008
- Recalling firm
- Bio-Rad Laboratories
- Product
- Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.
- Status
- Terminated
- Initiated
- 2007-09-05
- Posted
- 2007-10-31
- Terminated
- 2007-11-15
- Reason
- Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.
- Root cause
- Error in labeling
- Action
- On 9/5/07 a letter titled "IMPORTANT PRODUCT INFORMATION" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert. On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled "URGENT PRODUCT CORRECTION" and supplied a corrected package insert to replace the original insert sent.
- Quantity
- 46
- Distribution
- Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US.
- Lot, serial or model codes
- Lot 131BHH, Catalog # 26174
- 510(k) numbers
- not on file
- PMA numbers
- ["P060034"]
- Product code
- LOM
- Firm FEI
- 3008272466
- Firm city
- Redmond
- Firm state
- WA
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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