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U.S. Department of Health and Human Services

Class 2 Device Recall AnshLabs SARSCoV2 IgM ELISA (Capture)

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  Class 2 Device Recall AnshLabs SARSCoV2 IgM ELISA (Capture) see related information
Date Initiated by Firm December 18, 2020
Create Date January 11, 2021
Recall Status1 Terminated 3 on January 11, 2022
Recall Number Z-0842-2021
Recall Event ID 87057
Product Classification Reagent, coronavirus serological - Product Code QKO
Product 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.
Code Information Lot #/Expiration Date: 040720/2021-10-06, 041620/2021-10-15, 041720/2021-10-18, 042420/2021-10-15, 042720-A/2021-10-26
Recalling Firm/
Manufacturer		 Ansh Labs, LLC
445 W Medical Center Blvd
Webster TX 77598-4217
For Additional Information Contact Tom Verghese
281-404-0260
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 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 techsupport@anshlabs.com. www.anshlabs.com
Quantity in Commerce 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
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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