FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
- Recall number
- Z-1161-2013
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
- Status
- Terminated
- Initiated
- 2012-11-01
- Posted
- 2013-04-23
- Terminated
- 2017-03-30
- Reason
- Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.
- Root cause
- Under Investigation by firm
- Action
- Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letter dated November 1, 2012, to all affected customers via USPS. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue and discard any remaining recalled lots of VITROS Anti-HBS Reagent Packs. Foreign affiliates were informed by email on November 1, 2012, of the issue and instructed to notify their consignees of the issue and actions . On March 22, 2013, OCD sent customer letters via FedEX overnight and/or via USPS to US consignees for two additional lots of product being recalled. The letter provided similar recall instructions as the initial notification. Ortho Clinical Diagnostics has requested that their clients discontinue and discard any remaining inventory of VITROS Anti-HBS Reagent Packs subject to this recall. OCD has also requested that recall product recipients also complete a Confirmation of Receipt and return that document to OCD, fax to: 1-888-557-3759 or 585-453-4110. We apologize for any inconvenience this may cause your laboratory. If you have technical questions please contact Customer Technical Services at 1-800-421-3311. If you have questions about your replacement order, please call our Customer Service Center at 1-800-828-6316.
- Quantity
- 1464 units
- Distribution
- Worldwide Distribution- USA (nationwided) and countries of: Australia, Brazil, Canada, Chile, Chao Yang District, Beijing, Columbia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
- Lot, serial or model codes
- Lot #'s 6630 expiration 2/26/2013, Lot # 6740 expiration 6/18/2013 and Lot # 6750 expiration date 6/11/2013.
- 510(k) numbers
- not on file
- PMA numbers
- ["P000014/SO25"]
- 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