Recalls / —
—#165492
Product
VITROS Sodium Slides, Catalog # 837 9034
- FDA product code
- JGS — Electrode, Ion Specific, Sodium
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K924471
- Affected lot / code info
- UDI - 10758750004812 GENs- 8, 13, 14, 16, 17 & 18 Expiry Dates: 01-Nov-2018 through 01-Nov-2019
Why it was recalled
Potential for positively biased results
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
On 05 May 2018, Customer letter (Ref. CL2018-123) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all VITROS customers, who have a analyzer capable of running VITROS Na+ slides, to inform them of the issue and to request that they immediately discontinue use of this VITROS Na+ Slides, GENs 8 and 13. Continued use of VITROS Na+ Slides, GENs14,16,17& 18 is acceptable provided the conditions detailed in the communication are met. Foreign affiliates were initially informed by email on 05 May 2018 of the issue and instructed to notify their consignees of the affected product with this issue and the requirement to immediately discontinue use of the VITROS Na+ slides GENs 8, 13, 14, 16, 17 and 18. Due to the amount of time required to ship replacement product to some worldwide locations, a revised communication to the foreign affiliates occurred on 08 June 2018. Due to the health risk associated with potentially leaving the laboratory without a Na+ method, the revised letter instructs customers that they may continue to use GENs 14, 16, 17 and 18 until replacement product is received.
Recalling firm
- Firm
- Ortho-Clinical Diagnostics
- Address
- 513 Technology Blvd, Rochester, New York 14626-3601
Distribution
- Distribution pattern
- US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and the Netherlands
Timeline
- Recall initiated
- 2018-05-05
- Terminated
- 2021-02-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #165492. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.