Ortho Clinical Diagnostics Inc: VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

Recall number

Z-0770-2021

Recalling firm

Ortho Clinical Diagnostics Inc

Product

VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

Status

Open, Classified

Initiated

2020-12-11

Posted

2021-01-05

Terminated

not on file

Reason

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

Root cause

Under Investigation by firm

Action

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

Quantity

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, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.

Lot, serial or model codes

INITIAL Communication: 11 December 2020, (Communication Ref. # CL2020-302) Coatings 0230, 0231, 0233, 0235, 0239 (all lot numbers) Extended Recalls: Recall Extension #1, for VITROS CKMB Slides, Coating 0245 (Communication Reference, CL2021-182) 18 June 2021 Recall Extension #2 for VITROS CKMB Slides, Coating 0246 (Communication Reference, CL2021-214) 18 August 2021 Recall Extension #3 for VITROS CKMB Slides, Coating 0248 (Communication Reference, CL2021-274) , 1 November 2021 Recall Extension #4 for VITROS CKMB Slides, Coating 0261 (Communication Reference, CL2023-244) , 27 October 2023 UDI: (1) (10758750004294) (2) (10758750004201

510(k) numbers

["K861387"]

PMA numbers

not on file

Product code

JHS

Firm FEI

2250051

Firm city

Raritan

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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