Ortho-Clinical Diagnostics Recall: VITROS 4600 Chemistry System (VITROS 5,1 FS System fami
Ortho-Clinical Diagnostics Recall: VITROS 4600 Chemistry System (VITROS 5,1 FS System fami is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Ortho-Clinical Diagnostics; Product: VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in t
| Recalling firm | Ortho-Clinical Diagnostics |
|---|---|
| Product | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes. |
| 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. O |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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, Singapore, Spain, and Venezuela. |
| Recall initiated | 20130207 |
| Recall number | Z-1107-2013 |
| Category | device |
| State | NY |
| Country | United States |
$29/mo
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