# FDA recall Z-1598-2022

> **Mckesson Medical-Surgical Inc. Corporate Office** · Class II · device recall initiated 2022-05-25.

## Product

Strep test:  a.  McKesson Medical-Surgical	McKesson	Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003.   b.  QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274.   c.  Alere SAN DIEGO INC McKesson TEST, KIT STREP A DIPSTICK WAIVED (50/KT) Exempt Catalog #4999.   d.  In-Line Control Swab Quickvue In-Line Strep A Test Positive Level / Negative Level 12 Swabs (IVD) Catalog # 00345.   e.  (added 11/30/22) Abbott Rapid Test Kit Acceava Infectious Disease Immunoassay Strep A Test Throat Swab Sample 50 Tests, Model Number: 92001

## Reason for recall

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-1598-2022
- **Recalling firm:** Mckesson Medical-Surgical Inc. Corporate Office
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-25
- **Report date:** 2022-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1598-2022

## Citation

> AI Analytics. FDA recall Z-1598-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1598-2022. Source: US FDA. Licensed CC0.

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