FDA Device recall Z-1320-2013
QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of huma…
- FDA Device
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of huma… by Qiagen Gaithersburg, citing CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1320-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-30 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Qiagen Gaithersburg |
| Distribution | US |
Product
QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.
Reason
CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
Identifiers
| code_info | Catalog Number 4503225, Lot #142345648, Exp: 06/09/14 & Lot #142357718 Exp: 06/09/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1320-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.