# FDA recall Z-2310-2021

> **OPTI Medical Systems, Inc** · Class II · device recall initiated 2021-06-25.

## Product

OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003  b) 99-57004

## Reason for recall

The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.

## Distribution

Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados

## Key facts

- **Recall number:** Z-2310-2021
- **Recalling firm:** OPTI Medical Systems, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-25
- **Report date:** 2021-08-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Roswell, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2310-2021

## Citation

> AI Analytics. FDA recall Z-2310-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2310-2021. Source: US FDA. Licensed CC0.

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