Class 2 Device Recall Consult, Sofia, Alere San Diego, Quickvue, Acceava

• Date Initiated by Firm: May 25, 2022
• Date Posted: August 26, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1598-2022
• Recall Event ID: 90336
• 510(K)Number: K010582 K141775 K945080
• Product Classification: Antigens, all groups, streptococcus spp. - Product Code GTY
• 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
• Code Information: GTIN: a. 00612479240100; 00612479202733. b. 30014613202745. c. 00612479202726; 612479240094. d. 30014613003458. e. 10815845020031, 00815845020034.
• Recalling Firm/ Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office; 9954 Maryland Drive; Deep Run Iii Ste. 4000; Richmond VA 23233
• For Additional Information Contact: Ms. Ruby Upadhyaya ; 804-553-2281
• Manufacturer 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.
• FDA Determined Cause: Environmental control
• Action: Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 sedgwick@sedgwick.com. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. ¿ This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent possible patient harm. ¿ Please complete and return the enclosed response form as soon as possible even if you do not have any product on hand. ¿ Customers should contact Sedgwick directly by phone at 1-888-943-2401 to return the recalled products or if they have additional questions regarding this notification. Representatives are available Monday Friday, 8:00 am 5:00 pm PT
• Quantity in Commerce: a. 214 kits b. 1cs c. 53 kits d. 4 bx e. 1 KT
• Distribution: US Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GTY and Original Applicant = ACON LABORATORIES CO.; 510(K)s with Product Code = GTY and Original Applicant = QUIDEL CORP.; 510(K)s with Product Code = GTY and Original Applicant = QUIDEL CORPORATION