VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 680189
FDA device recall Z-1106-2013 · posted 2013-04-13 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.
- Action taken
- URGENT MEDICAL DEVICE CORRECTION letters were sent to the consignees on 2/07/13. On/about 2/07/13, OCD trained service personnel started to perform an assessment of all the VITROS System(s) in End-User facilities worldwide to determine if the extension springs are out of manufacturing specifications. In addition, the slide alignment guides will also be inspected. If the extension springs are out of specification they will be replaced. Consignees will also be provided with a communication that explains the issue.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- VITROS 5,1 FS: USA: 670 units, Foreign: 1249 units; VITROS 5,1 FS Refurbished: USA: 52 units, Foreign: 2 units
- Distribution
- Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, S
- Date initiated
- 2013-02-07
- Date posted
- 2013-04-13
- Date terminated
- 2017-04-20
- Location
- Rochester, NY
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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 |
| VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 (K031924) | Ortho-Clinical Diagnostics | 2003-08-07 |