Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Recalled by Mckesson Medical-Surgical Inc. Corporate Office Due to Facility Temperature excursions (from June 2021-August 2021) prior...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mckesson Medical-Surgical Inc. Corporate Office directly.
Affected Products
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
Quantity: a. 214 kits b. 1cs c. 53 kits d. 4 bx e. 1 KT
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mckesson Medical-Surgical Inc. Corporate Office
Mckesson Medical-Surgical Inc. Corporate Office has 276 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report