VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Sl

FDA device recall Z-0770-2021 · posted 2021-01-05 · Open, Classified

Recall details

Recalling firm

Ortho Clinical Diagnostics Inc

Reason for recall

VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

Action taken

Ortho Clinical Diagnostics (OCD) issued Urgent Product Correction Notification (CL2020-302) via ORTHO PLUSSM ( e-Communications, on 11 December 2020 to consignees. Letter states reason for recall, health risk and action to take: Per the VITROS CKMB Slides IFU, evaluate the Total CK value of the sample. For the respective CKMB coating, elevated total CK activity (>300 and <1000 U/L) may cause a significantly elevated VITROS CKMB Slides result. If the CK activity exceeds the value listed in the table on page 1, consult with your Medical Director. " Depending on which coating is used in your laboratory, you may want to consider an alternate method for samples with CK activity greater than indicated in the table on page 1. " If your laboratory chooses to discontinue using an affected coating, Ortho will credit your account. Current inventory levels do not allow for replacement. Provide credit quantity information using the Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than 22-DEC-2020. Note: complete the form even if your laboratory no longer has inventory of affected product. " Please forward this notification if the product was distributed outside of your facility. A VITROS CKMB Slides coating is currently being manufactured and is expected to be available in the first quarter of 2021. Ortho will continue to perform testing on all future coatings to evaluate CK-MM inhibition and will update the Technical Bulletin as appropriate. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311. Firm issued Extended Recalls viasent via eComm, FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (Ortho Direct, Dropship, Distributors and Federal Government): (1) Recall Extension #1, for VITROS CKMB Slides, Coating 0245 (Communication Reference, CL2021-182) On 18 June 2021. (2) Recall Extension #2 for VITROS CKMB Slides, Coating 0246 (Comm

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JHS

Quantity affected

Total= 41,598 U.S. = 403 xU.S. = 41,195; Extended: 25,775 units

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore 609917, United Kingdom, France, Germany, Ita

Date initiated

2020-12-11

Date posted

2021-01-05

Location

Raritan, NJ

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