BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,B
FDA device recall Z-2090-2015 · posted 2015-07-16 · Terminated
Recall details
- Recalling firm
- BD Biosciences, Systems & Reagents
- Reason for recall
- Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).
- Action taken
- BD Biosciences sent an Important Product Correction letter dated June 2015 to all affected customers. Customers were informed that a Field Service Engineer will schedule a time to perform the necessary correction. Customers with questions were instructed to contact BD Customer Support at 877-232-8995 (prompt 2). For questions regarding this recall call 408-954-6307.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 2188 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-06-15
- Date posted
- 2015-07-16
- Date terminated
- 2016-08-12
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 (K081213) | Bd Biosciences | 2008-08-14 |
| BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 (K062087) | Bd Biosciences | 2006-09-14 |
| BD FACSCANTO WITH BD FACSANTO SOFTWARE (K041074) | Bd Biosciences | 2004-09-17 |
| BD FACSCANTO SYSTEM (K040725) | Becton Dickinson Immunocytometry Systems | 2004-09-10 |
| FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET (K973483) | Becton Dickinson Immunocytometry Systems | 1998-02-17 |