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U.S. Department of Health and Human Services

Class 1 Device Recall Accula SARSCoV2 Test, REF: COV4100

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  Class 1 Device Recall Accula SARSCoV2 Test, REF: COV4100 see related information
Date Initiated by Firm April 06, 2022
Create Date May 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-1009-2022
Recall Event ID 90013
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
Product Accula SARS-CoV-2 Test, REF: COV4100
Code Information UDI/DI: B540COV41000; P22006-026, P22010-021, P22024-023, P22024-030, P22026-006, P22026-012, P22026-016 , P22010-001, P22010-030, P22024-026, P22024-032, P22026-007, P22026-013, P22026-017 , P22010-017, P22010-032, P22024-027, P22026-002, P22026-008, P22026-014, P22026-019 , P22010-019, P22024-021, P22024-028, P22026-004, P22026-009, P22026-015, P22032-011
Recalling Firm/
6190 Cornerstone Ct E Ste 220
San Diego CA 92121-4701
For Additional Information Contact Ron O'Brien
Manufacturer Reason
for Recall
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
FDA Determined
Cause 2
Material/Component Contamination
Action On 04/06/22, recall notices were mailed to customers. Customers were informed that the reliability of negative test results is not affected. Customers with affected devices were asked to do the following: 1. Discontinue use of any affected product immediately 2. All affected product must either be returned or discarded. Replacement product will be provided for all returned and discarded product upon receipt of Customer/Distributor Response Sheet. 3. Notify all impacted users in your facility. If you have shipped any of these lots outside of your facility, you must notify those customers or facilities of this voluntary recall. 4. Complete and return the Customer/Distributor Response Sheet, which can be emailed to USSD2.customercare@thermofisher.com Customers with questions are encouraged to contact the recalling firm at: +1-858-800-4929, or 1-800-955-6288, option 2.
Quantity in Commerce 6162
Distribution US Nationwide distribution in the states of CA, TX, MA, NY, FL, NC, NJ, GA, CO, HI, PA, WA, NY, VA, MD, KY, WI, IL, PR, ND, MI, TN, AZ, UT.
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.