QIAGEN artus CMV RG PCR ASR — Class II medical device recall Z-1321-2013
Terminated recall by QIAGEN Gaithersburg, Inc., reported 2013-05-22, distributed nationwide. CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
| Recall number | Z-1321-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | QIAGEN Gaithersburg, Inc., Gaithersburg, MD, United States |
| Recall initiated | 2013-01-30 |
| Classified | 2013-05-14 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2013-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 90 kits |
| Lot numbers | 142345647 |
| Model numbers | 4503223 |
| Expiration dates | 2014-06-09 |
Product
QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).
Reason for recall
CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1321-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.