PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, t
FDA device recall Z-0633-2013 · posted 2013-01-03 · Terminated
Recall details
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Reason for recall
- Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.
- Action taken
- Horiba Medical sent a Field Safety Notification and Acknowledgement Letter dated November 20, 2012, to all affected customers. The letter notified the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 calendar days via mail, email or fax. Customers with questions were instructed to contact their local representative. For questions regarding this recall call 714-273-9254.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 384 units
- Distribution
- Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
- Date initiated
- 2012-10-10
- Date posted
- 2013-01-03
- Date terminated
- 2013-09-12
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT (K103788) | HORIBA ABX SAS | 2011-11-08 |