Helix Elite SARS-CoV-2 Reference Standard Recalled for Unregistered UK Distribution
Microbiologics Inc. has recalled Helix Elite Inactivated SARS-CoV-2 reference standards distributed to the United Kingdom because the product was not registered for use in that region.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall with no reported safety defects, illnesses, or injuries. The reason for recall is regulatory non-compliance (unregistered distribution to the UK) rather than an inherent product safety hazard. FDA Class III recalls are typically assigned severity 1 or 2 per the rubric.
Plain-English summary
Microbiologics Inc. is recalling Helix Elite Inactivated Standard laboratory reference materials distributed to the United Kingdom. The recall includes two product codes: (a) Inactivated SARS-CoV-2 B.1.1.7 Whole Virus (UDI 10845357043846, Lot HE0071-01-1, expiration 12/31/2022), and (b) Inactivated SARS-CoV-2 B.1.351 Whole Virus (UDI 10845357043945, Lot HE0073-02-2, expiration 02/28/2023). These products are reference standards used in laboratories for virus testing and quality control.
The recall was issued because the product was not registered for use in the United Kingdom. The affected products were distributed internationally to the UK. No safety defects or illnesses have been reported in connection with these products.
The recalled product
- Product
- Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
- Manufacturer
- Microbiologics Inc
- Affected units
- 2
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 (5)
- a. UDI Number: 10845357043846
- Lot Number: HE0071-01-1
- Expiration Date: 12/31/2022. b. UDI Number: 10845357043945
- Lot Number: HE0073-02-2
- Expiration Date: 02/28/2023.
Distribution
Distribution scope not specified by the agency.
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