The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0080-2023·Announced 2022-10-19

Clip COVID Rapid Antigen Test Kit Recalled for Unapproved Shelf-Life Extension

LUMINOSTICS recalled Clip COVID test kits because the manufacturer extended shelf life and expiration dates without FDA approval. The extended expiration dates lack FDA validation.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: No illnesses, injuries, or test failures have been reported. The issue is a regulatory compliance matter involving shelf-life validation without FDA approval, constituting a voluntary precautionary recall of a Class II medical device.

Plain-English summary

LUMINOSTICS, Inc., doing business as Clip Health, is recalling Clip COVID Rapid Antigen Test Kit (25-pack) products, Catalog Number MDL002, that were distributed nationwide in the United States.

The recall was initiated because LUMINOSTICS extended the shelf life and expiration dates of these test kits based on internal stability testing without obtaining FDA approval or concurrence. The extended expiration dates were not validated by the FDA.

Approximately 10,037 boxes, each containing 25 test units, were affected by this recall. Specific lot numbers are listed in the official FDA recall notice. Customers can verify their product lot numbers and expiration information at expiry.clipcovid.com.

Consumers who possess affected test kits should verify the lot number against the recall information provided by the FDA. Tests should not be used beyond their originally validated expiration date. For detailed information and assistance, refer to the FDA recall notice or contact the manufacturer directly.

The recalled product

Product
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
Manufacturer
LUMINOSTICS, INC dba CLIP HEALTH
Category
Medical Device — COVID-19 Test Kit
Hazard

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 (20)

  • Lots: CC-10094-A
  • CC-10115-A
  • CC-10123-A
  • CC-10129-A
  • CC-10136-A
  • CC-10144-A
  • CC-10148-A
  • CC-10166-A
  • CC-10168-A
  • CC-10168-B
  • CC-10189-A
  • CC-10193-A
  • CC-10300-A
  • CC-10328-A
  • CC-10329-A
  • CC-10330-A
  • CC-10361-A
  • CC-10364-A
  • CC-10365-A
  • CC-10368-A

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · inaccurate results

See all →

Similar recalls