MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels ar
FDA device recall Z-1522-2015 · posted 2015-04-26 · Terminated
Recall details
- Recalling firm
- Beckman Coulter, Inc.
- Reason for recall
- Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28.
- Action taken
- Siemens sent an Urgent Medical Device Recall letter dated May 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The risk to health is explained and users are asked to discontinue use and discard any of the recalled lot still in inventory. No other lot numbers of the NBPC 34 panels are affected and may still be used. The Field Correction Effectiveness Check form should have been completed and returned to Siemens. PLEASE FAX THIS COMPLETED FORM TO 302-631-8467. Contact Siemens Customer Care Center or local Siemens Tech support. For further questions please call (916) 374-3031
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- JWY
- Quantity affected
- 681 boxes
- Distribution
- Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the states of: KS, LA, MD, NY, WV,NM, NH, MO, CT, MA, OK, NC. IA, OH. WI, TX, PA, MS and MN and to the countries of : Cana
- Date initiated
- 2014-05-14
- Date posted
- 2015-04-26
- Date terminated
- 2015-04-27
- Location
- West Sacramento, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICRODILUTION PANELS (K862140) | American Micro Scan | 1986-07-16 |