# FDA recall Z-2364-2020

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2020-05-11.

## Product

VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage:   For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

## Reason for recall

Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on  control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.

## Distribution

Worldwide distribution - US Nationwide including in the statesof Maine, Massachusetts, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington DC, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Alabama, Tennessee, Missouri, Mississippi, Kentucky, Ohio, Indiana, Michigan, Iowa, Wisconsin, Minnesota, South Dakota, North Dakota, Montana, Illinois, Kansas, Nebraska, Louisiana, Arkansas, Oklahoma, Texas, Colorado, Idaho, Utah, Arizona, New Mexico, California, Hawaii, Oregon , Washington, and Alaska

## Key facts

- **Recall number:** Z-2364-2020
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-11
- **Report date:** 2020-06-24
- **Termination date:** 2021-09-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2364-2020

## Citation

> AI Analytics. FDA recall Z-2364-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2364-2020. Source: US FDA. Licensed CC0.

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