Recall archive / FDA company announcement

Pilot: COVID-19 At-Home Test — FDA announcement May 5, 2023

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date May 5, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: COVID-19 At-Home Test
Reason: Due to microbial contamination in the liquid buffer solution.
Classification: Not supplied
Recalling firm: SD Biosensor, Inc.
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: 4d3134e290bada96

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	The affected tests can be identified by the lot number on the outer packaging and should be appropriately discarded. Dispose of the entire test kit in the household trash. Do not pour the liquid down the drain.; The affected test kits were distributed by Roche Diagnostics to distributors and retailers in the U.S. Product images, lot information and follow-up actions are available at go.roche.com/pilottest or by contacting the Roche Customer Support Center at 1-866-987-6243 and selecting option 1.; Lot Number; 53K38N1T1; 53K38N2T1; 53K38N3T1; 53K38N4T1; 53K38N5T1; 53K38P1T1; 53K38P2T1; 53K38P3T1; 53K41T5T1; 53K41X1T1; 53K41X2T1; 53K41X3T1; 53K4211T1; 53K4212T1; 53K4213T1; 53K4221T1; 53K4222T1; 53K4223T1; 53K4224T1; 53K4225T1; 53K4231T1; 53K4232T1; 53K4233T1; 53K4261T1; 53K4262T1; 53K4271T1; 53K4272T1; 53K4273T1; 53K4274T1; 53K4291T1; 53K4292T1; 53K42A1T1; 53K42A2T1; 53K42A3T1; 53K42E1T1; 53K42G1T1; 53K42G2T1; 53K42H1T1; 53K42H2T1; 53K42L1T1; 53K42L2T1; 53K4361AC; 53K4362AC; 53K4392AC

Label field

Details supplied by the agency

Lot, code or applicability

The affected tests can be identified by the lot number on the outer packaging and should be appropriately discarded. Dispose of the entire test kit in the household trash. Do not pour the liquid down the drain.; The affected test kits were distributed by Roche Diagnostics to distributors and retailers in the U.S. Product images, lot information and follow-up actions are available at go.roche.com/pilottest or by contacting the Roche Customer Support Center at 1-866-987-6243 and selecting option 1.; Lot Number; 53K38N1T1; 53K38N2T1; 53K38N3T1; 53K38N4T1; 53K38N5T1; 53K38P1T1; 53K38P2T1; 53K38P3T1; 53K41T5T1; 53K41X1T1; 53K41X2T1; 53K41X3T1; 53K4211T1; 53K4212T1; 53K4213T1; 53K4221T1; 53K4222T1; 53K4223T1; 53K4224T1; 53K4225T1; 53K4231T1; 53K4232T1; 53K4233T1; 53K4261T1; 53K4262T1; 53K4271T1; 53K4272T1; 53K4273T1; 53K4274T1; 53K4291T1; 53K4292T1; 53K42A1T1; 53K42A2T1; 53K42A3T1; 53K42E1T1; 53K42G1T1; 53K42G2T1; 53K42H1T1; 53K42H2T1; 53K42L1T1; 53K42L2T1; 53K4361AC; 53K4362AC; 53K4392AC

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Lot Number
53K38N1T1
53K38N2T1
53K38N3T1
53K38N4T1
53K38N5T1
53K38P1T1
53K38P2T1
53K38P3T1
53K41T5T1
53K41X1T1
53K41X2T1
53K41X3T1
53K4211T1
53K4212T1
53K4213T1
53K4221T1
53K4222T1
53K4223T1
53K4224T1
53K4225T1
53K4231T1
53K4232T1
53K4233T1
53K4261T1
53K4262T1
53K4271T1
53K4272T1
53K4273T1
53K4274T1
53K4291T1
53K4292T1
53K42A1T1
53K42A2T1
53K42A3T1
53K42E1T1
53K42G1T1
53K42G2T1
53K42H1T1
53K42H2T1
53K42L1T1
53K42L2T1
53K4361AC
53K4362AC
53K4392AC

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: May 5, 2023
Company announcement date: May 4, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.