PlainRecordsFDA · Medical device recall
VITROS 5,1 FS Chemistry System… and 1 more product
- 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 regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.
- 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 5,1 FS Chemistry System…
- Product
- VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing.
- Quantity
- 2,387 units Total (987 domestically & 1400 internationally)
- Codes and lots
- Product Code: 6801375, 6801890 Unique Device Identifier Numbers: 10758750001132, 10758750001644
- Recall started
- April 6, 2015
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Root cause (FDA)
- Software design
- What the company told customers
- Ortho Clinical Diagnostics distributed correction notification letters dated April 6, 2015, 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.
- Recall number
- Z-1728-2015
Assay Data Disk (ADD)…
- Product
- Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing
- Quantity
- 2,387 units Total (987 domestically & 1400 internationally)
- Codes and lots
- Product Code: 6801876 Unique Device Identifier Numbers: 10758750001576
- Recall started
- April 6, 2015
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Root cause (FDA)
- Software design
- What the company told customers
- Ortho Clinical Diagnostics distributed correction notification letters dated April 6, 2015, 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.
- Recall number
- Z-1729-2015
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1728-2015, Z-1729-2015. The agency record governs; check it and the company before acting.