ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnost
FDA device recall Z-2207-2015 · posted 2015-07-23 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Reason for recall
- System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems.
- Action taken
- Siemens sent an Urgent Medical Device Correction letter dated via Federal Express to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Field Correction Effectiveness Check attached to the letter. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- SMN10317708 = 20544 kits & SMN 10317709 = 21159 kits
- Distribution
- Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN,
- Date initiated
- 2015-05-19
- Date posted
- 2015-07-23
- Date terminated
- 2019-07-17
- Location
- East Walpole, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM (K053020) | Bayer Healthcare, LLC | 2005-12-30 |