# FDA recall Z-2578-2023

> **Instrumentation Laboratory** · Class II · device recall initiated 2023-07-13.

## Product

ACL TOP Family 50 Series Models as follows:  In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis                                                    (1) ACL TOP 550 CTS		Model Number: 00000280045;					  (2) ACL TOP 750 CTS		Model Number: 00000280055;					  (3) ACL TOP 350 CTS		Model Number: 00000280065;					  (4) ACL TOP 750			Model Number: 00000280015;					  (5) ACL TOP 750 LAS		Model Number: 00000280035					  (6) ACL TOP 970 CL(only available ROW)Model Number:  00000280097

## Reason for recall

Sample misidentification could occur under specific   conditions and patient management altered based on an incorrectly assigned result

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden.

## Key facts

- **Recall number:** Z-2578-2023
- **Recalling firm:** Instrumentation Laboratory
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-13
- **Report date:** 2023-09-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bedford, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2578-2023

## Citation

> AI Analytics. FDA recall Z-2578-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2578-2023. Source: US FDA. Licensed CC0.

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