FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
- Recall number
- Z-0557-2014
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
- Status
- Terminated
- Initiated
- 2013-10-25
- Posted
- 2013-12-20
- Terminated
- 2018-05-18
- Reason
- Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.
- Root cause
- Other
- Action
- On October 25, 2013, Ortho Clinical Diagnostics issued product correction notifications to their US customers via US Postal Service Priority Mail and email notices to their foreign affiliates informing them of the recall. Ortho Clinical Diagnostics advised their customers to review previously reported results between > 12 and <30 mIU/mL and consult the Laboratory Medical Director. Customers were instructed to utilize alternative methods for anti-HBs testing. Customers are advised to seek alternative methods for anti-HBs testing. For additional information, please contact the OCD Customer Technical Service representative at 1-800-421-3311.
- Quantity
- 1,920 kits
- Distribution
- Nationwide distribution - all states.
- Lot, serial or model codes
- Product Code 1) 6801926, 2) 6801925, 3) 6802452 Lot numbers: 1) 6700, 2) 6731, 3) 6830 Expiry Dates: 1) 21 May 2013, 2) 24 July 2013, 3) 11 Sept 2013
- 510(k) numbers
- not on file
- PMA numbers
- ["P000014","P000014S025"]
- Product code
- LOM
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- 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