Recall Z-1075-2016
Ortho-Clinical Diagnostics · initiated December 21, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. Product Usage: The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
Codes / lots: Software Version 2.8 and below; VITROS 5,1 FS Chemistry System Serial Numbers: J34000119 - J34002323; VITROS 5,1 FS Chemistry System (Refurbished) Serial Numbers: 34000133, 34000193, 34000197, 34000212, 34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799, 34000805, 34000833, 34000851, 34000893, 34000946, 34000947, 34001006, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274, 34001297, 34001317, 34001345, 34001378, 34001379, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840, 34001850, 34001875, 34001897, 34000123, 34000143, 34000191, 34000215, 34000219, 34000235, 34000251, 34000256, 34000260, 34000261, 34000319, 34000331, 34000380, 34000382, 34000406, 34000408, 34000412, 34000426, 34000431, 34000454, 34000464, 34000473, 34000501, 34000523, 34000530, 34000541, 34000542, 34000546, 34000548, 34000553, 34000558, 34000576, 34000577, 34000584, 34000585, 34000609, 34000612, 34000615, 34000616, 34000617, 34000618…
Reason for recall
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).
FDA-determined cause: Error in labeling
Action taken
Ortho Clinical Diagnostics sent an URGENT PRODUCT CORRECTION NOTIFICATION Letter (Ref. CL2015-201, dated December 21, 2015) via FedEx overnight courier and/or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address). The notification letter was sent to all customers who received the affected product. Foreign affiliates were informed by e-mail on 12/20/2015 of the issue and instructed to notify their consignees of the issue and required actions. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Technical Services at 1-800-421-3311.
Details
- Recall number
- Z-1075-2016
- Initiated
- December 21, 2015
- Posted by FDA
- March 8, 2016
- Terminated
- May 30, 2018
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- US = 994; Foreign = 1405
- Distribution
- Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1071-2016 Class II | VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No.…Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry… | 12/21/2015Terminated |
| Z-1072-2016 Class II | VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number…Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry… | 12/21/2015Terminated |
| Z-1073-2016 Class II | VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number…Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry… | 12/21/2015Terminated |
| Z-1074-2016 Class II | VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number…Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry… | 12/21/2015Terminated |