Z-2560-2025Class II

VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18...

Name: Z-2560-2025 VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2025-07-29
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2025-07-29 / Open, Classified / root cause: design

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests on 2025-07-29. FDA classified it as Class II and gives the reason as "VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2560-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-29
Posted: 2025-09-12
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Product code: KHP Acid, Lactic, Enzymatic Method
Reason for recall: VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
Root cause tag: design
FDA root cause: Device Design
Action: On 29 July 2025, QuidelOrtho mailed a hardcopy customer letter (Ref. CL2025-201) via FedEx overnight courier and/ or electronically sent the customer letter using ORTHO PLUS e-Communications to customers. Consignees were instructed to load ADD DRV 6339 (or above) on your VITROS XT 3400 and/or VITROS XT 7600 System(s), complete and return the provided Confirmation of Receipt, save the notification with your User Documentation or post this notification by each VITROS XT 3400/VITROS XT 7600 System in your laboratory until the issue has been resolved, and forward the information if affected units were further distributed.
Quantity in commerce: 2,320 units
Distribution: US Nationwide distribution.
Product codes and lots: Catalog number 8150112; UDI# 10758750004454; Coating 0130 and above, this includes Lot numbers 3533-0130-2947, 3533-0130-2972, 3533-0130-3001, 3533-0130-3002, 3533-0130-3048, 3533-0130-3084, 3533-0131-5887, 3533-0131-5958, 3533-0131-5962, 3533-0131-6058 ; Expiration date range 01-Oct-2026 to 01-Jan-2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2560-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2559-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-12
Z-2560-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-12

Product code KHP

K955286Class IIEktachem Clinical Chemistry Slide Glucose (Glu)Johnson & Johnson Clinical Diagnostics, Inc. / cleared 1996-05-17

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)