| | Class 1 Device Recall Accula SARSCoV2 Test, REF: COV4100 |  |
| 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/
Manufacturer |
MESA BIOTECH, INC
6190 Cornerstone Ct E Ste 220
San Diego CA 92121-4701
|
| For Additional Information Contact | Ron O'Brien
858-863-7972 |
|---|
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.
|
|
|
|
