FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
- Recall number
- Z-0476-2019
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
- Status
- Terminated
- Initiated
- 2018-10-08
- Posted
- not on file
- Terminated
- 2022-10-13
- Reason
- VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
- Root cause
- Under Investigation by firm
- Action
- Ortho Clinical Diagnostics issue the customer notification on October 8, 2018, provides information regarding the potential for biased results when using VITROS dLDL Reagent, Generations (GENs) 26 and 27. Actions to take: For GEN 26: Discontinue using GEN 26 and switch to an alternate GEN of product as soon as possible. Please specify full or partial sales units remaining and indicate credit or replacement on your Confirmation of Receipt form. " For GEN 27: Install ADD DRV 6003 on your VITROS System upon receipt. Following a successful recalibration, resume using VITROS dLDL Reagent, GEN 27 remaining in your inventory. " Complete the Confirmation of Receipt form and return by October 22, 2018. Questions contact our Ortho Care" Technical Solutions Center at 1-800-421-3311
- Quantity
- 5850 units
- Distribution
- Nationwide Foreign: Australia Belgium Bermuda, HM11 Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Poland Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom
- Lot, serial or model codes
- Lot Numbers: 1517-26-6396 (expires 6-Nov-2018) 1517-26-6582 (expires 2-Feb-2019) 1517-26-6639 (expires 2-Feb-2019) 1517-27-6808 (expires 7-May-2019)
- 510(k) numbers
- ["K041720"]
- PMA numbers
- not on file
- Product code
- MRR
- 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