# FDA recall Z-1097-2022

> **Randox Laboratories Ltd.** · Class III · device recall initiated 2022-03-25.

## Product

CK MB Calibrator, Catalogue Number CK2393

## Reason for recall

Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.

## Distribution

Domestic distribution to WV and PR. International distribution to Bangladesh, Bosnia & Herzegovina, Botswana, China, Colombia, Costa Rica, Croatia, Egypt, Fiji, France, Georgia, Germany, Ghana, Greece, Grenada, Hong Kong, India, Iraq, Italy, Lithuania, Malaysia, Maldives, Malta, Mexico, Morocco, Mozambique, Nepal, Nigeria, Pakistan, Philippines, Poland, Puerto Rico, Romania, Russia, Saudi Arabia, South Korea, Switzerland, Thailand, Turkey, UK, Uruguay, Uzbekistan and Vietnam.

## Key facts

- **Recall number:** Z-1097-2022
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-25
- **Report date:** 2022-05-25
- **Termination date:** 2023-12-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1097-2022

## Citation

> AI Analytics. FDA recall Z-1097-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1097-2022. Source: US FDA. Licensed CC0.

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