Z-2358-2023Class II

VITROS Immunodiagnostic Products Troponin I ES Calibrators

Name: Z-2358-2023 VITROS Immunodiagnostic Products Troponin I ES Calibrators
Creator: Ortho-Clinical Diagnostics
Published: 2023-06-05
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2023-06-05 / Open, Classified / root cause: manufacturing process

FDA source

ORTHO-CLINICAL DIAGNOSTICS began a recall of VITROS Immunodiagnostic Products Troponin I ES Calibrators on 2023-06-05. FDA classified it as Class II and gives the reason as "Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results". 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-2358-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-05
Posted: 2023-08-08
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products Troponin I ES Calibrators
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were sent a recall notification by mail dated 06/05/2023. The notification that customers immediately discontinue use of affected devices and discard any remaining inventory. Any discarded product will be replaced by QuidelOrtho or credit will be provided. Customers are asked to return the provided Confirmation of Receipt Form no later than 06/12/2023. If affected devices were further distributed customers are asked to forward the provided notification to those downstream customers. This notice is to be posted by all VITROS Systems until the expiration of affected devices, which is 06/10/2023. Customers with any questions may contact Quidel Ortho at 1-800-421-3311.
Quantity in commerce: 4,013 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: Product Code: 6802302; UDI-DI: 10758750002511; Lot No.: 4800; Expiration Date: 10-Jun-2023.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2358-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2357-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-08
Z-2358-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-08

Product code MMI

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)