FDA Medical Device Recalls (openFDA)
ORTHO-CLINICAL DIAGNOSTICS: VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
- Recall number
- Z-1707-2015
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Product
- VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
- Status
- Terminated
- Initiated
- 2015-05-06
- Posted
- 2015-06-04
- Terminated
- 2017-09-13
- Reason
- The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
- Root cause
- Error in labeling
- Action
- On 5/06/2015, Customer Letter and Verification Form (Ref. CL15-095) were sent notifying the users of the issue and advised them of the required actions. The notification was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. On 5/06/2015, Distributor Letter (Ref. DL15-095) was sent via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and actions. For questions,questions, please contact Customer Technical Services at 1-800-421-3311 at any time.
- Quantity
- Domestic: 898 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot 3082, expiry date 7/27/2015
- 510(k) numbers
- ["K964310"]
- PMA numbers
- not on file
- Product code
- CDP
- 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