VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a vari...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1107-2013.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1107-2013.
Recall terminated by FDA.
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- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1107-2013.
Ortho-Clinical Diagnostics
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Ortho-clinical Diagnostics Recall FAQ
Ortho-clinical Diagnostics is the subject of a medical devices safety report: VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a vari.... The notice was published on February 7, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 58 units are potentially affected.