Z-2073-2025Class II

VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a...

Name: Z-2073-2025 VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2025-06-12
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2025-06-12 / Open, Classified

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents... on 2025-06-12. FDA classified it as Class II and gives the reason as "Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2073-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-12
Posted: 2025-07-02
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.
Product code: DJG Enzyme Immunoassay, Opiates
Reason for recall: Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.
FDA root cause: Under Investigation by firm
Action: Quidel Ortho notified consignees on about 06/12/2025 via FedEx letter. Distributors were instructed to discontinue distribution and discard inventory of any affected lots, send the provided customer letter and Confirmation of Receipt to any affected customers, and complete and return their Confirmation of Receipt. Customers were instructed that if their laboratory is unable to generate QC results within acceptable range using lots from GEN 15 of VITROS OP Reagent, discontinue using, render unusable, and discard your inventory of VITROS OP Reagent, GEN 15. Additionally, there were requested to complete and return the Confirmation of Receipt, maintain the notification with all records, and provide the notification if affected units were further distributed.
Quantity in commerce: 2,017 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Product codes and lots: Model Number: 680 1997. UDI-DI: 10758750001835. Lot Numbers: 1527-15-2749 (exp. 17-Nov-2025), 1527-15-2771 (exp. 17-Dec-2025), 1527-15-2818 (exp. 11-Apr-2026), 1527-15-2871 (exp. 15-May-2026).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2073-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2073-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-02

Product code DJG

K062460Class IIVitros Chemistry Products Op Reagent, Calibrator Kit 26 and Dat Performance Verifiers I, II and IIIOrtho-Clinical Diagnostics, Inc. / cleared 2006-12-15

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)