The Recall Desk
HighFDA (Devices)·Z-0195-2022·Announced 2021-11-10

Siemens COVID-19 Diagnostic Assay Recalled for Inadequate Validation Data

Siemens is recalling Atellica IM SARS-CoV-2 Antigen Assay kits because validation data submitted to the FDA was insufficient to confirm the assay's accuracy for its intended use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II medical device recall involves a diagnostic assay for a high-risk pathogen with inadequate validation data. Although no illnesses or injuries have been reported, the insufficient validation presents a potential risk of inaccurate test results, meeting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Siemens Healthcare Diagnostics, Inc is recalling 149 kits of the Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), lot numbers 44989001 (expiration 2021-10-07) and 60407003 (expiration 2021-11-12). This in vitro diagnostic device is used to detect SARS-CoV-2 antigen in clinical specimens.

The recall was initiated because data provided in the Emergency Use Authorization (EUA) submission to the FDA was insufficient to determine that the assays were adequately validated for their intended use. The FDA classified this as a Class II recall.

The affected kits were distributed nationwide in 15 U.S. states and territories: Alaska, California, Colorado, the District of Columbia, Georgia, Illinois, Maine, North Carolina, Nevada, New York, Oregon, Pennsylvania, Puerto Rico, Virginia, and the U.S. Virgin Islands.

Healthcare facilities and laboratories that have received these kits should discontinue use and contact Siemens Healthcare Diagnostics for further instructions regarding return or replacement of the product.

The recalled product

Product
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Manufacturer
Siemens Healthcare Diagnostics, Inc
Category
Medical Device — Diagnostic Assay
Hazard
  • inadequate-validation
  • inaccurate-test-results

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot # 44989001 - Exp. Date 2021-10-07
  • UDI # (01)00630414611846(10)44989001(17)20211007
  • Lot # 60407003 - Exp. Date 2021-03-22
  • UDI # (01)00630414611846(10)60407003(17)20211112.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category