FDA Medical Device Recalls (openFDA)
QIAGEN Gaithersburg, Inc.: 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).
- Recall number
- Z-1321-2013
- Recalling firm
- QIAGEN Gaithersburg, Inc.
- 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).
- Status
- Terminated
- Initiated
- 2013-01-30
- Posted
- 2013-05-14
- Terminated
- 2013-07-01
- Reason
- CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
- Root cause
- Mixed-up of materials/components
- Action
- Qiagen Gaithersburg, Inc. issued a PRODUCT FIELD ACTION letter dated February 4, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect the vials prior to use to ensure that the vials are labeled "CMV RG Master" Vials labeled "EBV TM Master" should NOT be used and count the vials and discard per internal laboratory procedures. Qiagen will replace free of charge or credit any kits discovered with incorrect master mix vials. Please complete page 2 of this notice as soon as possible and email or fax it back to us at: (661) 702-3854, techservice-na@qiagen.com. If you have additional questions or concerns polease do not hestiate to call QIAGEN Technical Services at 1-800-344-3631 option 2 or by e-mail techservice-na@qiagen.com.
- Quantity
- 90 kits in total
- Distribution
- USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL.
- Lot, serial or model codes
- Catalog Number 4503223, Lot #142345647, Exp: 06/09/14
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LKQ
- Firm FEI
- 3003572099
- Firm city
- Gaithersburg
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28