FDA Medical Device Recalls (openFDA)
ORTHO-CLINICAL DIAGNOSTICS: VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.
- Recall number
- Z-2145-2016
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Product
- VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.
- Status
- Terminated
- Initiated
- 2016-05-09
- Posted
- not on file
- Terminated
- 2018-06-08
- Reason
- Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.
- Root cause
- Nonconforming Material/Component
- Action
- The firm, Ortho Clinical Diagnostics, sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Customer Letter (Ref. CL2016-098) dated 5/9/2016, via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received the affected product. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue distributing and discard the affected lots; complete and return the Confirmation of Receipt form by May 18, 2016 via Fax to 1.888.557.3759 or 1.585.453.4110 or scan to PDF and email to: ConfirmationAdmin@its.jnj.com, and forward this notification if you have distributed these systems outside of your facility. If you have any questions, contact Customer Technical Services at 1-800-421-3311.
- Quantity
- US: Lot 6471 - 282, Lot 6480 - 344
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lots 6471 (expiry date 19-Jul-2016), 6480 (expiry date 23-Aug-2016)
- 510(k) numbers
- ["K983031"]
- PMA numbers
- not on file
- Product code
- LOJ
- Firm FEI
- 3007111389
- Firm city
- Bridgend
- Firm state
- not on file
- Firm country
- United Kingdom
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