Z-2624-2023Class II

VITROS XT Chemistry Products ALKP Slides

Name: Z-2624-2023 VITROS XT Chemistry Products ALKP Slides
Creator: Ortho-Clinical Diagnostics, INc.
Published: 2023-08-05
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2023-08-05 / Open, Classified

FDA source

Ortho-Clinical Diagnostics, INc. began a recall of VITROS XT Chemistry Products ALKP Slides on 2023-08-05. FDA classified it as Class II and gives the reason as "Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2624-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-05
Posted: 2023-09-21
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS XT Chemistry Products ALKP Slides
Product code: CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Reason for recall: Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
FDA root cause: Under Investigation by firm
Action: An "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letter dated 08/17/2023 was issued to impacted consignees. Consignees are provided instructions to utilize when reviewing sample results and any result between 600-1500 U/L should be diluted using a 10x dilution and retested. A confirmation of receipt of the recall letter should be completed and returned by August 25, 2023. Please forward this notification if the affected product was distributed outside your facility. Save this notification with your documentation or post this notification by each VITROS 250/350/FS 5,1/4600/5600/XT 3400/XT 7600 System until the issue has been resolved. If your laboratory has experienced this issue with the product and has not already done so, please report the occurrence to your local Ortho Care Technical Solutions Center. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.
Quantity in commerce: 402,966 units
Distribution: Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to countries of: Bermuda, Belgium, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Italy, India, Japan, Mexico, Netherlands, Norway, Singapore, Spain, Sweden, Portugal, Russia, United Kingdom
Product codes and lots: Product Code: 1053180 UDI:(10758750008346) GEN #21; Expiry Date Range 01 Jul 2023 - 01 June 2024 GEN #23; Expiry Date Range 01 Oct 2023 - 01 Sep 2024 GEN #26; Expiry Date Range 01 Aug 2023 - 01 Dec 2024 GEN #28; Expiry Date Range 01 Aug 2024 GEN #29; Expiry Date Range 01 Sep 2024 - 01 Dec 2024 GEN #30; Expiry Date Range 02 Jan 2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2624-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2623-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-21
Z-2624-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-21

Product code CJE

K946090Class IKodak Ektacchem 950Irc AnalyzerClinical Diagnostic Systems, Inc. / cleared 1995-01-17

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)