SporeTraq 12-test mail-in spore testing service used incorrect incubation
The SporeTraq Mail-In Spore Testing Service, 12 tests, is being recalled because an incorrect incubation process was performed on the product.
What this means for you
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: FDA Class II recall for a processing deviation in a testing service with no clinical consequence described in the source, which fits the Moderate band.
Plain-English summary
The SporeTraq Mail-In Spore Testing Service, 12 tests, model/catalog number 1023770, from HF Acquisition Co LLC, is being recalled.
The stated reason is that an incorrect incubation process was performed on the product. The recall notice identifies the required incubation periods that were not followed, including 24 hours for spore strips used in steam sterilizers and 72 hours for spore strips used in chemiclave sterilizers. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was nationwide in the United States across 41 states. The service is used by healthcare and dental practices rather than sold to consumers.
Practices should identify affected tests using the catalog number and the lot list in the recall notice and follow the instructions issued by the firm.
The recalled product
- Product
- Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strip
- Manufacturer
- HF Acquisition Co LLC
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 (3)
- 52 TESTS
- 1023770 SPORETRAQ MAIL-IN SPORE TESTING SERVICE
- 12 TESTS or other products serviced by Mesa Labs.
Distribution
Part of a larger recall action
This product is one of 2 recalled by HF Acquisition Co LLC 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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