Z-0712-2024Class II

QMS Tacrolimus Calibrators, Product code 10015573

Name: Z-0712-2024 QMS Tacrolimus Calibrators, Product code 10015573
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2023-11-21
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2023-11-21 / Open, Classified / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of QMS Tacrolimus Calibrators, Product code 10015573 on 2023-11-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0712-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-21
Posted: 2024-01-11
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: QMS Tacrolimus Calibrators, Product code 10015573
Product code: JIT Calibrator, Secondary
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 10 sales units US; 1 sales unit OUS
Distribution: Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
Product codes and lots: No UDI Lot 74859619, Expiry 11-May-2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0712-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0712-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-11

Product code JIT

K123343Class IIThermo Scientific Qms Tacrolimus Assay and CalibratorsMicrogenics Corp. / cleared 2013-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)