Z-0842-2021Class II

AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample...

Name: Z-0842-2021 AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample...
Creator: Ansh Labs, LLC
Published: 2020-12-18
License: https://open.fda.gov/license/

Ansh Labs, LLC / initiated 2020-12-18 / Terminated / root cause: design

FDA source

Ansh Labs, LLC began a recall of 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... on 2020-12-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0842-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-18
Posted: 2021-01-11
Terminated: 2022-01-11
Recalling firm: Ansh Labs, LLC
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.
Product code: QKO Reagent, Coronavirus Serological
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.
Root cause tag: design
FDA 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 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
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
Product codes and lots: Lot #/Expiration Date: 040720/2021-10-06, 041620/2021-10-15, 041720/2021-10-18, 042420/2021-10-15, 042720-A/2021-10-26

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0842-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0842-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-11

Product code QKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)