Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the
FDA device recall Z-1704-2017 · posted 2017-04-03 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.
- Action taken
- Beckman Coulter sent an Urgent Medical Device Recall letter dated February 13, 2017, was sent to customers to inform them that Beckman Coulter has identified a mismatch in Rack ID Labels (REF MU9074); the Rack ID number displayed and the Rack ID barcode label do not match. Rack ID labels numbered 0161 thru 0180 may be read as 0141 thru 0160 on the AU System. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact their Customer Support Center: http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 in the United States and Canada; Outside the United States and Canada, contact their Beckman Coulter representative.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 2 sheets (20 labels/sheet)
- Distribution
- US Distribution : MA ., Internationally to Japan
- Date initiated
- 2017-02-13
- Date posted
- 2017-04-03
- Date terminated
- 2017-04-12
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AU5800(R) CHEMISTRY ANALYZER (K112412) | Beckman Coulter, Inc. | 2011-12-23 |
| OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER (K961274) | Olympus America, Inc. | 1996-07-05 |