| Class 1 Device Recall Pilot COVID19 AtHome Test |  |
Date Initiated by Firm | March 31, 2023 |
Date Posted | May 23, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1594-2023 |
Recall Event ID |
92137 |
Product Classification |
Coronavirus antigen detection test system. - Product Code QKP
|
Product | Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728) |
Code Information |
Lot Numbers: 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
53K38N3T1
53K38N2T1
53K38N1T1
53K38N4T1
53K38N5T1
53K38P1T1
53K38P2T1
53K38P3T1 |
Recalling Firm/ Manufacturer |
SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire Bldg, 16, Deogyeong-Daero Suwon Korea (the Republic of)
|
For Additional Information Contact | go.roche.com/pilottest 1-866-987-6243 |
Manufacturer Reason for Recall | The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose. |
FDA Determined Cause 2 | Material/Component Contamination |
Action | Press release issued 5/4/23 by SD BioSensor:
https://www.prnewswire.com/news-releases/recall-notice---sd-biosensor-inc-requests-discontinuation-of-use-and-disposal-of-specific-pilot-covid-19-at-home-tests-in-the-united-states-due-to-microbial-contamination-in-the-liquid-buffer-solution-301816494.html
A notification letter titled "Subject: Statement about the patient risk assessment for the Extraction buffer of Pilot" COVID-19 At-Home Test" dated 3/31/23 was sent to Roche.
A Roche URGENT MEDICAL DEVICE REMOVAL notification letter dated 5/4/23 was sent to customers.
. Assess your current inventory, quarantine, and discontinue distribution of all affected PilotTM COVID-19 At-Home Test kits, and Roche will contact you in the near future to discuss final actions related to the affected product in your inventory.
. If you distributed product to consumers, make information in the enclosed Pilot COVID-19 At-Home Test Consumer Message (TP-01837) available to your consumers per your established process for recall notification.
. Complete all sections of the enclosed Recall Response form (TP-01836) and return it according to the instructions on the form.
. Maintain this Urgent Medical Device Removal (UMDR) for future reference.
In addition to this communication to U.S. distributors, as part of a media release on May 03, 2023, consumers are being asked to stop using and discard affected test kits, and contact Roche directly for follow-up actions.
Questions
Product images, lot information, and consumer actions are available at go.roche.com/pilottest or by contacting the Roche Support Network Customer Support Center at 1-866-987-6243 and select option 1. |
Quantity in Commerce | 2,712,767 kits |
Distribution | US Nationwide. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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