Z-1876-2025Class II

VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a...

Name: Z-1876-2025 VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2025-04-14
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2025-04-14 / Open, Classified / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides on 2025-04-14. FDA classified it as Class II and gives the reason as "Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label". 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-1876-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-14
Posted: 2025-05-29
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Product code: DCK C-Reactive Protein, Antigen, Antiserum, And Control
Reason for recall: Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An URGENT PRODUCT CORRECTION NOTIFICATION was mailed to consignees. The notification to distributors instructs consignees to forward the provided notification and Customer Confirmation Receipt to all customers who were shipped affected lots and to discontinue distributing affected lots. Affected lots in possession of distributors should be discarded. Distributors are asked to return a completed Distributor Confirmation Receipt form. The notification to customers instructs consignees to check their inventory and destroy any identified product subject to this recall. Consignees are instructed to post the provided notification near all VITROS devices and within device User Documentation until the issue has been resolved. A copy of the recall notification should be forwarded if a unit was distributed outside your facility. Consignees are to complete and return the provided Confirmation of Receipt form.
Quantity in commerce: 3,587 units
Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CO, FL, GA, ID, IL, IN, KS, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WI, WV & WY and the countries of Canada, Chile, Colombia, France, India, Italy, Mexico & Singapore.
Product codes and lots: Catalog number: 8097990; GTIN#: 10758750004355; Coating Number: 1291; Lot No. 3788-1291-0019, 3788-1291-0052, 3788-1291-0078, 3788-1291-0079, 3788-1291-0080, 3788-1291-9975.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1876-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1876-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-29

Product code DCK

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)