PlainRecordsFDA · Medical device recall
VITROS 5,1 FS Chemistry System… and 2 more products
- Date
- April 24, 2013
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Ortho-Clinical Diagnostics
- Reason
- 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.
- Distribution pattern
- 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.
3 products in this recall
VITROS 5,1 FS Chemistry System…
- Product
- VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes.
- Quantity
- VITROS 5,1 FS: USA: 670 units, Foreign: 1249 units; VITROS 5,1 FS Refurbished: USA: 52 units, Foreign: 2 units
- Codes and lots
- VITROS 5,1 FS Chemistry System Serial Numbers: 34000119 through 34002273; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers: 34000133, 34001240, 34000193, 34001243, 34000212, 34001248, 34000316, 34001251, 34000318, 34001274, 34000337, 34001297, 34000360, 34001311, 34000420, 34001317, 34000451, 34001345, 34000478, 34001378, 34000495, 34001389, 34000497, 34001390, 34000529, 34001396, 34000538, 34001422, 34000552, 34001472, 34000557, 34001504, 34000596, 34001569, 34000601, 34001572, 34000631, 34001589, 34000642, 34001610, 34000799, 34001633, 34000805, 34001668, 34000833, 34001809, 34000851, 34001840, 34000893, 34001850, 34000947, 34001897, 34001172, 34001218
- Recall started
- Feb. 7, 2013
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- 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.
- Recall number
- Z-1106-2013
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)…
- 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.
- Quantity
- USA: 58 units, Foreign: 103 units
- Codes and lots
- Serial Numbers 46000108 through 46000217
- Recall started
- Feb. 7, 2013
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- 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.
- Recall number
- Z-1107-2013
VITROS 5600 Integrated System…
- Product
- VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
- Quantity
- USA: 775 units, Foreign: 800 units
- Codes and lots
- Serial Numbers 56000118 through 56001583
- Recall started
- Feb. 7, 2013
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- 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.
- Recall number
- Z-1108-2013
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1106-2013, Z-1107-2013, Z-1108-2013. The agency record governs; check it and the company before acting.