enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For
FDA device recall Z-1677-2014 · posted 2014-06-02 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur as operator is not alerted that results have not been produced and that further actions are required.
- Action taken
- US consignees were sent Urgent Product Correction Letters (Cl2014-102, dated 3/20/2014) on 3/20/2014 by FedEx or USPS (for PO Box addresses only) overnight mail, informing them of the issue and instructing them to ensure that all required data elements are entered and in the correct format when using the auto verification feature or custom rules. J&J Foreign affiliate consignees were notified by e-mail on 3/20/2014 informing them of the issue.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- Domestic: 20 units, Foreign: 61 units
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, P
- Date initiated
- 2014-03-20
- Date posted
- 2014-06-02
- Date terminated
- 2017-04-11
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (K063144) | Ortho-Clinical Diagnostics, Inc. | 2006-11-13 |