FDA · Medical device recall

VITROS 4600 Chemistry System… and 1 more product

June 17, 2015 Class II

Date: June 17, 2015
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: Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.
Distribution pattern: Worldwide Distribution-US (nationwide), Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.

2 products in this recall

VITROS 4600 Chemistry System…

Product: VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Quantity: 255 units total (131 domestically & 255 internationally)
Codes and lots: Product Code: 6802445 Unique Device Identifier No.: 10758750012343
Recall started: April 6, 2015
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Software design
What the company told customers: On April 6, 2015, Ortho Clinical Diagnostics distributed correction notification letters and response forms to their customers via courier service. All urine patient results that require pretreatment was advised to refer to the notice of correction for instructions. Correction notices should also be posted beside the device user documentation for easy reference. Customers were advised to complete and return the Confirmation of Receipt before April 20, 2015. Customers with questions may contact the Customer Technical Service at 1-800-421-3311 anytime..***CAPA***Since the Assay Data Disk (ADD) provides data tables that determine which assays can be tested from the same sample container, an updated ADD is being created to address the anomaly on the VITROS 4600 and 5600. The anomaly will be addressed with an updated ADD is uploaded and the revised ADD mitigates the issue totally. Anticipated date of availability TBD.
Recall number: Z-1742-2015

VITROS 5600 Chemistry System…

Product: VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Quantity: 1895 units total (907 domestically & 988 internationally)
Codes and lots: Product Code: 6802413 Unique Device Identifier No.: 10758750002740
Recall started: April 6, 2015
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Software design
What the company told customers: On April 6, 2015, Ortho Clinical Diagnostics distributed correction notification letters and response forms to their customers via courier service. All urine patient results that require pretreatment was advised to refer to the notice of correction for instructions. Correction notices should also be posted beside the device user documentation for easy reference. Customers were advised to complete and return the Confirmation of Receipt before April 20, 2015. Customers with questions may contact the Customer Technical Service at 1-800-421-3311 anytime..***CAPA***Since the Assay Data Disk (ADD) provides data tables that determine which assays can be tested from the same sample container, an updated ADD is being created to address the anomaly on the VITROS 4600 and 5600. The anomaly will be addressed with an updated ADD is uploaded and the revised ADD mitigates the issue totally. Anticipated date of availability TBD.
Recall number: Z-1743-2015

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1742-2015, Z-1743-2015. The agency record governs; check it and the company before acting.

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