VITROS XT Chemistry Products ALKP Slides

FDA device recall Z-2624-2023 · posted 2023-09-21 · Open, Classified

Recall details

Recalling firm

Ortho-Clinical Diagnostics, INc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CJE

Quantity affected

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, Jap

Date initiated

2023-08-05

Date posted

2023-09-21

Location

Rochester, NY

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