Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro diagnostic test intende
FDA device recall Z-3039-2011 · posted 2011-08-19 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Siemens Healthcare Diagnostic has confirmed a high frequency of "Abnormal assay" flags and imprecision. Test results across the assay range may be falsely depressed or elevated, as much as, 1.93 mg/dL at a concentration of 9.26 mg/dL.
- Action taken
- An Urgent Field Safety Notice datey July 2011 was issued to all affected customers. Customers are being advised to immediately discontinue use and discard any remaining inventory of Dimension(R) CA Flex(R0 reagent cartridge - lot EA2153. Replacement order for the affected lot is in process, and will be sent to impacted customers free of charge. Customers were instructed to forward the Field Safety Notice to anyone whom they may have distributed the affected product. For questions regarding this recall call 302-631-6299.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 2500 cartons
- Distribution
- Worldwide Distribution to Guam, Puerto Rico, Chile, Costa Rica, Venezuela, South Korea, Vietnam and domestically to AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MN, MI,
- Date initiated
- 2011-07-19
- Date posted
- 2011-08-19
- Date terminated
- 2013-12-27
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM (K860021) | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-11 |