FDA · Medical device recall

VITROS Chemistry Products Cl- Slides… and 1 more product

Sept. 19, 2018 Class III

Date: Sept. 19, 2018
Risk class: Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)
Status: Terminated
Filed by: Ortho-Clinical Diagnostics
Reason: The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.
Distribution pattern: Worldwide Distribution - US Nationwide and in the countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.

2 products in this recall

VITROS Chemistry Products Cl- Slides…

Product: VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Quantity: 128196
Codes and lots: GEN 5 and below
Recall started: July 11, 2018
Device type: Electrode, Ion-Specific, Chloride
Root cause (FDA): Under Investigation by firm
What the company told customers: On 7/11/18, Important Product Correction Notification letters were distributed to customers. The letters instructed customers to perform the following actions: VITROS Cl- Slides and VITROS CREA Slides Instructions for Use will be updated to contain the revised information described in this letter; we will notify you upon availability. In the interim, retain a copy of this customer letter for your records. Calibration Diskette and ADD Data Release Version (DRV) 5992 (and above) will support the revised measuring range for VITROS CREA Slides. We anticipate that DRV 5992 will be available beginning on July 28, 2018 by eConnectivity or will be sent via your normal Cal Disk or ADD mailing. Prior to the availability of the revised IFU, be aware that if a serum or plasma sample contains a Triglyceride concentration of 600 mg/dL or higher, the Chloride result may be positively biased by approximately 2.1 mmol/L. Follow your normal laboratory procedures as you would for other known assay interferences. Note: It is acceptable to continue using VITROS Cl- Slides. Upon availability, install the Calibration Diskette or ADD to implement the revised Measuring Range: For VITROS 4600, 5600 or 5,1 FS Systems: Install ADD DRV 5992 or above, Select All Assay Data option For VITROS 250/350 Systems: Install Calibration Diskette DRV 5992 or above Refer to the enclosure for additional instructions to update the Measuring Range. Update laboratory procedures and your Laboratory Information System (LIS), as necessary. Retain this letter until we send a notification to alert you when the revised IFUs are available. Complete the Confirmation of Receipt form and return by July 25, 2018. Post this notification by each system that processes VITROS Cl- or CREA Slides. Forward this notification if the product was distributed outside of your facility.
Recall number: Z-3043-2018

VITROS Chemistry Products Cl- Slides…

Product: VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Product Usage:
Quantity: 420105
Codes and lots: GEN 10 and above
Recall started: July 11, 2018
Device type: Calibrator, Multi-Analyte Mixture
Root cause (FDA): Under Investigation by firm
What the company told customers: On 7/11/18, Important Product Correction Notification letters were distributed to customers. The letters instructed customers to perform the following actions: VITROS Cl- Slides and VITROS CREA Slides Instructions for Use will be updated to contain the revised information described in this letter; we will notify you upon availability. In the interim, retain a copy of this customer letter for your records. Calibration Diskette and ADD Data Release Version (DRV) 5992 (and above) will support the revised measuring range for VITROS CREA Slides. We anticipate that DRV 5992 will be available beginning on July 28, 2018 by eConnectivity or will be sent via your normal Cal Disk or ADD mailing. Prior to the availability of the revised IFU, be aware that if a serum or plasma sample contains a Triglyceride concentration of 600 mg/dL or higher, the Chloride result may be positively biased by approximately 2.1 mmol/L. Follow your normal laboratory procedures as you would for other known assay interferences. Note: It is acceptable to continue using VITROS Cl- Slides. Upon availability, install the Calibration Diskette or ADD to implement the revised Measuring Range: For VITROS 4600, 5600 or 5,1 FS Systems: Install ADD DRV 5992 or above, Select All Assay Data option For VITROS 250/350 Systems: Install Calibration Diskette DRV 5992 or above Refer to the enclosure for additional instructions to update the Measuring Range. Update laboratory procedures and your Laboratory Information System (LIS), as necessary. Retain this letter until we send a notification to alert you when the revised IFUs are available. Complete the Confirmation of Receipt form and return by July 25, 2018. Post this notification by each system that processes VITROS Cl- or CREA Slides. Forward this notification if the product was distributed outside of your facility.
Recall number: Z-3044-2018

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

Source: FDA · Medical device enforcement reports, recall numbers Z-3043-2018, Z-3044-2018. The agency record governs; check it and the company before acting.

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