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
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test kits distributed nationwide between June 1, 2021 and September 30, 2021. The recall was issued because the test kits experienced temperature excursions (exposure to higher than appropriate temperatures) at a facility between June and August 2021 prior to delivery, which may have reduced the product's effectiveness.
The affected products include multiple lots identified by specific GTINs and lot codes. The recall involves a total of approximately 272 individual test kits and boxes distributed across the United States. The source document does not specify a remedy or recommended action for consumers who may have received these products.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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 Quantity: a. 214 kits b. 1cs c. 53 kits d. 4 bx e. 1 KT Lot/code info: GTIN: a. 00612479240100; 00612479202733. b. 30014613202745. c. 00612479202726; 612479240094. d. 30014613003458. e. 10815845020031, 00815845020034.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.