Ansh Labs, LLC Recall 87057
Description: 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.
Ansh Labs, LLC Recall 87057 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0842-2021 |
| Event ID | 87057 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution including in the states of TX, MO, OK, MD, FL, NY, OR, GA, NC. OUS: None |
| Quantity | 327 kits (93 test per kit) |
| Recall 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. |
| Device Classification | 20210120 |
| Device Code Info | Lot #/Expiration Date: 040720/2021-10-06, 041620/2021-10-15, 041720/2021-10-18, 042420/2021-10-15, 042720-A/2021-10-26 |
| Center Classification Date | 20210111 |
| Recall Initiation Date | 20201218 |
| Recalling Firm | Ansh Labs, LLC |
| Initial Notification | Letter |
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