PlainRecordsFDA · Medical device recall
VITROS Chemistry Products Specialty Diluent… and 1 more product
- Date
- May 7, 2014
- 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
- Distribution pattern
- Nationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
2 products in this recall
VITROS Chemistry Products Specialty Diluent…
- Product
- VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
- Reason
- Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.
- Quantity
- 1656 distributed (1200 went to warehouse in France)
- Codes and lots
- Lot F3168 (exp. 30 Sep 2014)
- Recall started
- March 26, 2014
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Root cause (FDA)
- Other
- What the company told customers
- On 3/26/2014, Urgent Product Correction Notification Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected lot(s), discard the affected lots and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Replacement product will be sent for the product discarded. J&J Foreign affiliate consignees were notified by e-mail informing them of the issue on 3/26/2014.
- Recall number
- Z-1519-2014
VITROS Chemistry Products FS Diluent Pack 3…
- Product
- VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626
- Reason
- Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.
- Quantity
- 1042 distributed (220 went to warehouse in France)
- Codes and lots
- Lot 01-3266 (exp. 23-SEPTEMBER-2014)
- Recall started
- March 26, 2014
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Root cause (FDA)
- Other
- What the company told customers
- On 3/26/2014, Urgent Product Correction Notification Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected lot(s), discard the affected lots and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Replacement product will be sent for the product discarded. J&J Foreign affiliate consignees were notified by e-mail informing them of the issue on 3/26/2014.
- Recall number
- Z-1520-2014
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1519-2014, Z-1520-2014. The agency record governs; check it and the company before acting.