Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl,
FDA device recall Z-2730-2017 · posted 2017-07-13 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.
- Action taken
- Recall notices will be sent via mail or email to customers the week of 05/15/2017. Customers are instructed to discard the affected calibrator and request a replacement. Call Client Services at (800) 526-3821 (US only)
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 4444 AQUA CAL Level 1 kits
- Distribution
- US Nationwide Distribution in the states of AL, AR, AK, CA, CO, DE, FL, GA, ID, IL, IN, IO, KS, KY, LA, MA, MD, MS, MI, ME, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WV,
- Date initiated
- 2017-05-15
- Date posted
- 2017-07-13
- Date terminated
- 2020-09-09
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS (K071277) | Beckman Coulter, Inc. | 2007-06-01 |