# FDA recall Z-3017-2018

> **Remel Inc** · Class II · device recall initiated 2018-08-13.

## Product

remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K  (a) 10ML, REF 07182  (b) 10ML, REF 07180  (c) 5ML, REF 064732  (d) 5ML, REF 064730  (e) 9ML, REF 064720

## Reason for recall

Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

## Distribution

US, Canada, Singapore

## Key facts

- **Recall number:** Z-3017-2018
- **Recalling firm:** Remel Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-13
- **Report date:** 2018-09-19
- **Termination date:** 2019-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lenexa, KS, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3017-2018

## Citation

> AI Analytics. FDA recall Z-3017-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3017-2018. Source: US FDA. Licensed CC0.

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