# FDA recall Z-0676-2018

> **Hologic, Inc.** · Class II · device recall initiated 2017-11-29.

## Product

Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200

## Reason for recall

Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.

## Distribution

United States (US), Guam (GU), Japan (JP)

## Key facts

- **Recall number:** Z-0676-2018
- **Recalling firm:** Hologic, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-29
- **Report date:** 2018-02-28
- **Termination date:** 2018-08-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0676-2018

## Citation

> AI Analytics. FDA recall Z-0676-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-0676-2018. Source: US FDA. Licensed CC0.

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