FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics, Inc.: QMS Tacrolimus Calibrators, Product code 10015573
- Recall number
- Z-0712-2024
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Product
- QMS Tacrolimus Calibrators, Product code 10015573
- Status
- Open, Classified
- Initiated
- 2023-11-21
- Posted
- 2024-01-11
- Terminated
- not on file
- Reason
- Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the affected lot may results in erroneous calibration results, causing delay in testing.
- Root cause
- Storage
- Action
- On 21 November 2023, all consignees who were shipped the VITROS QMS Tacrolimus Calibrators Lot 74859619 expiry date: 11-May-2024 from QuidelOrtho distribution center were notified of the issue and instructed to: -Discontinue using, render unusable, and discard your inventory of QMS Tacrolimus Calibrators, Lot 74859619, which was shipped to the laboratory from QuidelOrtho. -Post the notification by the laboratory s inventory storage area until a replacement lot of QMS Tacrolimus Calibrator has been received. -Forward the notification if the affected product was distributed outside their facility. If you have questions about this recall, please contact QuidelOrtho's Global Services Organization (formerly Ortho Care) at 1-800-421-3311.
- Quantity
- 10 sales units US; 1 sales unit OUS
- Distribution
- Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
- Lot, serial or model codes
- No UDI Lot 74859619, Expiry 11-May-2024
- 510(k) numbers
- ["K123343"]
- PMA numbers
- not on file
- Product code
- JIT
- 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