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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 149
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
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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