Who else makes this device?

Name: Sporetraq Mail-IN Spore Testing Service, 52 Tests
Brand: Sporetraq Mail-IN Spore Testing Service, 52 Tests

General Hospital › MonitoringIndicator, Biological Sterilization Process

Sporetraq Mail-IN Spore Testing Service, 52 Tests

Catalogue number 1023780, listed by HF Acquisition Co. LLC, United States, under Indicator, Biological Sterilization Process. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

3recalls on this code

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FRC
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15

Record

Regulatory record for Sporetraq Mail-IN Spore Testing Service, 52 Tests
Listed by	HF Acquisition Co. LLC, United States
FDA product code	FRC
Device type	Indicator, Biological Sterilization Process
Device class	Class 2
Regulation	21 CFR 880.2800
Establishment	Repacker / relabeller, Manufacturer
510(k)	K032914
Record published	2025-06-23

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Sporetraq Mail-IN Spore Testing Service, 52 Tests
Catalogue number	Size	Status
1023780		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bionova®	Terragene S.A.	47
Attest™	3M Company	36
Verify	Steris Corporation	27
3M™ Attest™	3M Company	16
Celerity	Steris Corporation	15
Biotrace™	Terragene S.A.	11
Single Species BI Strip	Crosstex International	11
Tuttnauer®	Terragene S.A.	10
Sterrad Velocity™	Advanced Sterilization Products Services Inc.	8
GPS	Group Practice Solutions	7
Henry Schein	Henry Schein, Inc.	7
Propper Duo Spore Biological Indicators	Propper Manufacturing Co., Inc.	7

Showing 12 of 173. All products under Indicator, Biological Sterilization Process

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Sporetraq Mail-IN Spore Testing Service, 52 Tests
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
HF Acquisition Co. LLC	510(k) number	2026-04-13	Class II	Under Investigation by firm	Due to incorrect incubation process being performed on product.	2210
HF Acquisition Co. LLC	510(k) number	2026-04-13	Class II	Under Investigation by firm	Due to incorrect incubation process being performed on product.	0

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2024-12-11	Class II	Error in labeling	Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer’s account.	4,021

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.