AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.

Labeling update; To reduce the risk of false positive/false negative results the IFU for the adaptive immune response to SRS-CoV-2 testing is being updated to remove Plasma as a "sample type" and to update the "limitation" section to include potential cross-reactivity with non-SARS-CoV2 strains.

On 12/18/2020 and on 12/30/2020, Ansh Labs, sent a "Urgent: Medical Device Voluntary Correction" notification to all affected consignees via E-Mail. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Previous versions of SARS-CoV2 IgM ELISA IFU.AL.1002 (Revision No.: 01 - 04) should be removed and discarded. The attached updated revision, SARS-CoV2 IgM ELISA IFU.AL.1002 (Revision No.: 05) should be used. 2. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. 3. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 4. Please complete and return the attached Acknowledgement and Receipt Form within 10 days so we are assured you have received this important communication. 5. If you have any questions, please contact Ansh Labs at 281-404-0260, Monday through Friday 8:30 AM to 5:30 PM, Central Standard Time or at [email protected]. www.anshlabs.com