FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories, Inc.: The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
- Recall number
- Z-1840-2015
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Product
- The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
- Status
- Terminated
- Initiated
- 2015-05-13
- Posted
- 2015-06-25
- Terminated
- 2015-11-05
- Reason
- The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.
- Root cause
- Incorrect or no expiration date
- Action
- Bio-Rad Laboratories Inc, sent an Urgent Product Correction letter dated May 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalled calibrator is a spare component which is sold separately from the MONOLISA Anti-HBs EIA Kit and the kit is not affected by this recall. Customers were informed that testing was performed and the Anti-HBs 10 mLU/mL Calibrator was acceptable to use through the expiration date of the kit dated 2015-11-30. Customers with questions can call the firm at 1-800-224-6723, option #2, then #3.
- Quantity
- 20 vials
- Distribution
- US Distribution to the states of : AZ, CA, ID, MO, and NH.
- Lot, serial or model codes
- lot no. 11130382, expiration date 2016-04-30
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJX
- 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