Reference Source

RR Donnelley Global Turnkey Solutions · 89-08 · MEXICO

For RR Donnelley Global Turnkey Solutions · 89-08 · MEXICO, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is MEXICO; product is Exa SARS- CoV-2 Rapid Antigen Test; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 04/04/2022; address is Blvd Internacional 881 , San Jeronimo, Cd , Juarez, Chihuahua MEXICO, verified against its source on 2026-09-16.

Firm
RR Donnelley Global Turnkey Solutions verified
Import alert
89-08
Import alert name
"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
Country
MEXICO verified
Address
Blvd Internacional 881 , San Jeronimo, Cd , Juarez, Chihuahua MEXICO verified
Date published
04/04/2022 verified
Product code
83 Q - - KP Coronavirus antigen detection test system. verified
Product
Exa SARS- CoV-2 Rapid Antigen Test verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

RR Donnelley Global Turnkey Solutions Date Published : 04/04/2022 Blvd Internacional 881 , San Jeronimo, Cd , Juarez, Chihuahua MEXICO 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/04/2022 Desc: Exa SARS- CoV-2 Rapid Antigen Test

accessdata.fda.gov, retrieved 2026-09-15

Source

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