Recall Z-0842-2021 ยท QKO Reagent, Coronavirus Serological
Ansh Labs, LLC
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 sus
| Date | Dec 18, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 Sy |
| Quantity | 327 kits (93 test per kit) |
| Distribution | US Nationwide distribution including in the states of TX, MO, OK, MD, FL, NY, OR, GA, NC. OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.