Ortho-Clinical is recalling QMS Tacrolimus Calibrators (Lot 74859619, exp. May 2024) due to improper storage that may cause inaccurate test results. Affected units could delay critical testing.
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.
Take action
Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
“Ortho-Clinical QMS Tacrolimus Calibrators Recall: Improper Storage Causes Erroneous.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56774-ortho-clinical-qms-tacrolimus-calibrators-recall-improper-storage-causes-erroneous. Based on FDA recall #Z-0712-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0712-2024%22&limit=1).
The FDA announced on November 21, 2023, that Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators due to improper storage expected to degrade quality and render them unsuitable for use. The agency issued recall number Z-0712-2024.
How to tell if you have it
Brand: Ortho-Clinical
Product: QMS Tacrolimus Calibrators
Product code: 10015573
Lot code: 74859619
Expiry date: May 11, 2024
The hazard
The FDA states that improper storage is expected to degrade the calibrator's quality. Use of the affected lot may result in erroneous calibration results, causing delay in testing.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since July 10, 2017. Recent brand recalls include Ortho-Clinical LAC Slides Recall dated July 29, 2025, and Ortho-Clinical VITROS Ca Slides Recall dated July 9, 2025. Other recent recalls of similar products include Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026), Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026), and Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026).
How to tell if you have this one
Check for the product code 10015573 and lot number 74859619 with an expiration date of May 11, 2024. The recall applies to calibrators sold by Ortho-Clinical.
Brand
Ortho-Clinical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Expiration Date
Verify the expiration date on the calibrator label is May 11, 2024.
Where it went and when
Where it was distributed
Distributed in 6 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Illinois, Indiana, New Jersey, New Mexico, Texas.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0712-2024 (November 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0712-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.